Stryker Announces Rejuvenate Hip Implant Recall…Quietly

July 5th, 2012. By AbiK

The Canadian Stryker Rejuvenate Hip Implant recall was the tip-off.

For patients who’ve undergone hip replacement surgery and have sat and followed the legal news about the alleged DePuy Hip problems (both the DePuy Pinnacle and the DePuy ASR), and the Zimmer Hip problems (the Durom cup)—both utilizing metal-on-metal componentry that’s alleged to be defective—the Stryker hip recall in Canada had to have sparked the question: why if the same hip implant is recalled there hasn’t it been recalled here?

Well, now it has. Only it’s been a rather quiet recall announcement.

Stryker has announced a voluntary recall of the Stryker Rejuvenate Modular and ABG II modular-neck hip stems. The recall by Stryker was voluntary. The reason the recall was initiated is because of potential risks associated with modular-neck stems. The risks, as reported on the Stryker website, include the potential for “fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.”

As with the previous metal-on-metal hip implant components, which led to hip implant lawsuits, the alleged issue is an increased risk of metallosis—which can occur as the metal hip components rub against each other, thereby releasing particles of cobalt and chromium into the blood. According to Stryker, if you are experiencing pain or swelling at the joint site, you should speak with your hip surgeon.

While the US Stryker voluntary recall does not specify model numbers, the following information and model numbers were identified in the Health Canada recall notification:

Trade Name

A) Rejuvenate Modular Neck, 0 DEG
B) Rejuvenate Modular Neck, 8 DEG
C) Rejuvenate Modular Neck, 16 DEG
D) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ

Recall Posting Date

2012-05-28

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2012-04-30

Recall Number

73679

Hazard Classification

Type II

Model or Catalog #

A) NLS-300000B, NLS-340000B, NLS-380000B, NLS-420000B
B) NLV-300800G, NLV-300800Y, NLV-340800G, NLV-340800Y, NLV-380800G, NLV-380800Y, NLV-420800G, NLV-420800Y
C) NLS-301600P, NLS-341600P, NLS-3816000P, NLS-4216000P
D) SPT-070000S, SPT-080000S, SPT-090000S, SPT-100000S, SPT-110000S, SPT-120000S

Lot or Serial #

A) All lots
B) All lots
C) All lots
D) All lots

Reason for Recall

Stryker Orthopedics has updated the instructions for use (IFU) for the Rejuvenate Modular Hip System. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction.

If you’re experiencing pain or swelling in the area of your hip replacement, regardless of which manufacturer and/or model of hip implant you have, speak to your hip surgeon.

Tags: Hip Implant lawsuit, Hip Replacement Surgery, Metal-on-Metal hip implant, Stryker Hip Recall, Stryker Rejuvenate Hip Recall, stryker-orthopedics-rejuvenate-modular-hip-system

This was posted on Thursday, July 5th, 2012 at 3:02 pm and is filed under Defective Products, Drugs/Medical, Emerging Issues, lawsuits . Feel free to respond, or trackback. Read our comments policy.