MAUDE Adverse Event Report: STRYKER GMBH X3 HUMERAL INSERT - 32MM X 4 CONSTRAINED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5571-C-3204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/29/2020
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 is not available; hospital retained.
Event or Problem Description
It was reported that the patient's right reverse shoulder was revised due to dislocation of the poly insert from the glenoid component.Rep reported no further information will be available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as the x-rays & patient activity levels, as well as the affected device must be available in order to determine the root cause of the complaint 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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient's right reverse shoulder was revised due to dislocation of the poly insert from the glenoid component.Rep reported no further information will be available.Additionally reported: all implants were replaced, with the exception of the humeral stem.Patient was unaware of her shoulder dislocating, presented to emergency room with unrelated medical issue.Dislocation was noticed on x-ray taken for this unrelated medical issue.It is unknown if the patient has been compliant.X-rays are unavailable.

• Brand Name: X3 HUMERAL INSERT - 32MM X 4 CONSTRAINED
• 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: 10308718
• Report Number: 0008031020-2020-01942
• Device Sequence Number: 16358674
• Product Code: KWS
• UDI-Device Identifier: 07613327098556
• UDI-Public: 07613327098556
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 01/31/2024
• Device Model Number: 5571-C-3204
• Device Catalogue Number: 5571-C-3204
• Device Lot Number: 2M3LH5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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: Required Intervention
• Patient Age: 78 YR