MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE TRIAL - 36MM X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5901-C-3602
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
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: "placing trial noticed that one of the tabs had come off.".
Event or Problem Description
As reported: "placing trial noticed that one of the tabs had come off.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the product was returned but could not be inspected at the moment because of the facility access restrictions in place due to the covid-19 pandemic.The case will be reassessed as soon as the restriction is lifted.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
As reported: "placing trial noticed that one of the tabs had come off.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: one of the pegs on the border of the device is broken making the instrument unusable.This device was manufactured in 2016, and has been properly functioning for 4 years.Normal wear can therefore be considered the root cause of the event.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.

• Brand Name: GLENOSPHERE TRIAL - 36MM 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: 9924846
• Report Number: 0008031020-2020-01060
• Device Sequence Number: 16958245
• Product Code: KWS
• UDI-Device Identifier: 07613327100471
• UDI-Public: 07613327100471
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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 Model Number: 5901-C-3602
• Device Catalogue Number: 5901-C-3602
• Device Lot Number: MAC11A02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/07/2020; 07/02/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/02/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1