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

Catalog Number	WACM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2008
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The manufacturer became aware of adverse events from the national joint replacement registry of the australian orthopedic 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 CARPAL IMPLANT MEDIUM
• Common Device Name: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7803369
• Report Number: 0008031020-2018-00565
• Device Sequence Number: 1197814
• Product Code: JWJ
• UDI-Device Identifier: 00886385015507
• UDI-Public: 00886385015507
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K021859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: WACM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention