MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 52X17; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5552-E-5217
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330); Injury (2348)
Date of Event	06/09/2020
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 retained by hospital.
Event or Problem Description
It was reported that the patient's left shoulder was revised due to discomfort and range of motion.The 52x17 humeral head of the reunion total shoulder was swapped.
Additional Manufacturer Narrative
The reported event that reunion tsa - sr 4mm offset humeral head 52x17 was alleged of 'adverse impact to patient - postoperatively' 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 x-rays -rays would help determine if the size chosen was the appropriate one, and would help determine the root cause of the complaint event.Note, the operative technique determines the proper way to choose the appropriate size of the humeral head.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 left shoulder was revised due to discomfort and range of motion.The 52x17 humeral head of the reunion total shoulder was swapped.

• Brand Name: REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 52X17
• 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: 10237153
• Report Number: 0008031020-2020-01846
• Device Sequence Number: 19439541
• Product Code: KWS
• UDI-Device Identifier: 07613327098044
• UDI-Public: 07613327098044
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• 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): 08/19/2020

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: 02/29/2024
• Device Model Number: 5552-E-5217
• Device Catalogue Number: 5552-E-5217
• Device Lot Number: 5H433Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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 Weight: 92