MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - SR STANDAR D HUMERAL HEAD 52X17; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5552-S-5217
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right shoulder was revised due to pain.The humeral head was revised.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was not returned for evaluation and but the provided image confirms the revision surgery, but pain can not be confirmed without medical documents.A device inspection was not possible since the affected device was not returned, and with the provided picture of the explanted humeral head, no damage is visible.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.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.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 pain.The humeral head was revised.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was not returned for evaluation and but the provided image confirms the revision surgery, but pain can not be confirmed without medical documents.A device inspection was not possible since the affected device was not returned, and with the provided picture of the explanted humeral head, no damage is visible.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: REUNION TSA - SR STANDAR D HUMERAL HEAD 52X17
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach NJ 2545 ; SZ 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22441296
• Report Number: 0008031020-2025-01046
• Device Sequence Number: 7904535
• Product Code: KWS
• UDI-Device Identifier: 07613327097832
• UDI-Public: 07613327097832
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 05/01/2020
• Device Catalogue Number: 5552-S-5217
• Device Lot Number: 2Y8L9N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 98 KG