MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE TRIAL - 32MM X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5901-C-3202
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
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
As reported: "doctor was trialing glenosphere and tried to remove it with forceps.It would not come off baseplate.He then removed it with an osteotome, breaking the trial glenosphere".
Additional Manufacturer Narrative
The reported could be confirmed.The device inspection reveals the following: the product returned presents multiple scratches and wear marks all over.Furthermore, two out of the 4 pegs of the device are broken and have not been returned.Based on the state of the device, the functionality can not be given anymore.These marks confirm that the device was mishandled during 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.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "doctor was trialing glenosphere and tried to remove it with forceps.It would not come off baseplate.He then removed it with an osteotome, breaking the trial glenosphere".

• Brand Name: GLENOSPHERE TRIAL - 32MM 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: 9323875
• Report Number: 0008031020-2019-01670
• Device Sequence Number: 14213641
• Product Code: KWS
• UDI-Device Identifier: 07613327100457
• UDI-Public: 07613327100457
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/20/2019

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: Health Professional
• Device Catalogue Number: 5901-C-3202
• Device Lot Number: A1GP0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1