MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - X3 PEGGED GLENOID - SIZE 48; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5542-P-0048
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/06/2019
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.Retained by hospital.
Event or Problem Description
It was reported that the patient's right shoulder was revised due to instability.The patient's total shoulder was converted to a reverse shoulder (humeral head and glenoid were revised).
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.It was reported that no further information will be released by the hospital or surgeon.More detailed information about the complaint event 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 shoulder was revised due to instability.The patient's total shoulder was converted to a reverse shoulder (humeral head and glenoid were revised).

• Brand Name: REUNION TSA - X3 PEGGED GLENOID - SIZE 48
• 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: 8941791
• Report Number: 0008031020-2019-01184
• Device Sequence Number: 13977908
• Product Code: KWS
• UDI-Device Identifier: 07613327097658
• UDI-Public: 07613327097658
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 05/01/2022
• Device Catalogue Number: 5542-P-0048
• Device Lot Number: WL78R5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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: 55 YR