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

Model Number	5573-C-3202
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
As reported: "we did a shoulder replacement and after surgery he got post op xrays noticed the glenosphere wasn¿t seated correctly.Went back the next day and removed the glenosphere and reattached it correctly." additionally reported: "patient stay was prolonged.Stayed overnight had revision the next day and recovery delayed 24 hours.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Based on investigation, the root cause was attributed to be user related.The failure was likely caused by not properly checking that the glenosphere is seated correctly on the base plate, as per indication in the operative technique guide.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "we did a shoulder replacement and after surgery he got post op xrays noticed the glenosphere wasn¿t seated correctly.Went back the next day and removed the glenosphere and reattached it correctly." additionally reported: "patient stay was prolonged.Stayed overnight had revision the next day and recovery delayed 24 hours.".

• Brand Name: GLENOSPHERE - 32MM 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: 9845749
• Report Number: 0008031020-2020-00733
• Device Sequence Number: 14174634
• Product Code: KWS
• UDI-Device Identifier: 07613327098877
• UDI-Public: 07613327098877
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2024
• Device Model Number: 5573-C-3202
• Device Catalogue Number: 5573-C-3202
• Device Lot Number: 5Y1R46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR