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

Model Number	5573-C-3602
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
Primary procedure, right reverse shoulder.It was reported that upon opening the glenosphere, the impactor would not insert into the implant due to foreign matter in the screw hole of the implant.A second implant of a different size was available and used instead to complete the surgery successfully with a delay of approximately 3-4 minutes.
Additional Manufacturer Narrative
Correction: refer to d9/h3 device availability.The reported event could be confirmed.It could be confirmed that the debris reported in the complaint was a plug used to protect the threads of the glenosphere during the polishing phase of the device during manufacturing.The plug was not taken out during production and stayed into the device, and was observed by the end customer during surgery.A corrective action report has been opened in order to further investigate and address this issue for further details.A review of the device history for the reported lot did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Primary procedure, right reverse shoulder.It was reported that upon opening the glenosphere, the impactor would not insert into the implant due to foreign matter in the screw hole of the implant.A second implant of a different size was available and used instead to complete the surgery successfully with a delay of approximately 3-4 minutes.

• Brand Name: GLENOSPHERE - 36MM DIA 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: 10026911
• Report Number: 0008031020-2020-01424
• Device Sequence Number: 2714782
• Product Code: KWS
• UDI-Device Identifier: 07613327098884
• UDI-Public: 07613327098884
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/18/2020

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 Expiration Date: 11/30/2024
• Device Model Number: 5573-C-3602
• Device Catalogue Number: 5573-C-3602
• Device Lot Number: 952YT7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR