MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE TRIAL - 40MM X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5901-C-4002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Upon incoming inspection, items were visibly worn.No associated procedure.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate use / maintenance or simply due to normal wear and tear.The device inspection revealed the following: the returned devices are indeed damaged / broken off as reported, which lead us believe that inadequate handling during use has been the cause as this was found upon inspection.Note that these devices are several years old though and therefore must have been in good use (normal wear and tear over the years in use).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Upon incoming inspection, items were visibly worn.No associated procedure.

• Brand Name: GLENOSPHERE TRIAL - 40MM X 2MM THK CONCENTRIC
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8958200
• Report Number: 0008031020-2019-01230
• Device Sequence Number: 13991094
• Product Code: KWS
• UDI-Device Identifier: 07613327100495
• UDI-Public: 07613327100495
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 5901-C-4002
• Device Lot Number: MAC8E11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1