MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 01/01/2009

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 unknown.

Event Description

The manufacturer became aware of a study from (b)(6). The title of this study is (b)(6) and is associated with the remotion total wrist system. Within that publication, post-operative complications/ adverse events were reported, which occurred between 2009 and 2015. It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication; therefore, 30 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses lysis. 7 out of 22 cases.

• Brand Name: UNKNOWN REMOTION WRIST CARPAL BALL IMPLANT
• Type of Device: IMPLANT
• 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8409544
• MDR Text Key: 138445951
• Report Number: 0008031020-2019-00219
• Device Sequence Number: 0
• Product Code: JWJ
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/26/2019
• 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 Treatment Data

Date Received: 03/11/2019 Patient Sequence Number: 1