MAUDE Adverse Event Report: STRYKER GMBH WRIST LEFT RADIAL IMPLANT, MEDIUM; PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Catalog Number WARLM

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

The manufacturer became aware of adverse events from the (b)(6) association.The report is associated with the remotion system, within that report, 3 post-operative complications/ revisions were reported, which occurred in 2008, 2009 and 2013.The reason for revision were loosening (1 case), implant breakage wrist plate (1 case) and infection (1 case).A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 3 complaints were initiated retrospectively.This product inquiry addresses revision surgery due to loosening.

• Brand Name: WRIST LEFT RADIAL IMPLANT, MEDIUM
• Type of Device: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7803357
• MDR Text Key: 117830596
• Report Number: 0008031020-2018-00564
• Device Sequence Number: 1
• Product Code: JWJ
• UDI-Device Identifier: 00886385015538
• UDI-Public: 00886385015538
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K021859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: WARLM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention