MAUDE Adverse Event Report: STRYKER STRYKER REJUVENATE STEM

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 12/07/2016

Event Type  Injury  

Event Description

The pt had a revision of a right tha secondary to failed hardware on a recalled implant.The stryker rejuvenate stem was implanted in 2010 at another facility.Per the provider, this device has gone on to a high failure rate with eventual recall.The pt had a slow progression of increased pain as well as increasing metal levels in his serum testing which required the tha revision.Unable to identify serial marking on stem.Markings on head removed: 524039, v40, 36mm.

• Brand Name: STRYKER REJUVENATE STEM
• Type of Device: STRYKER REJUVENATE STEM
• Manufacturer (Section D): STRYKER ; kalamazoo MI 49002
• MDR Report Key: 6173712
• MDR Text Key: 62428696
• Report Number: MW5066694
• Device Sequence Number: 1
• Product Code: MEH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 90