MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - PRESS-FIT HUMERAL STEM 12MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5569-P-2012
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
This is a legal case being reported.This product inquiry is for the revision surgery due to implants 'coming apart/ shifting' in (b)(6) 2022.Another product inquiry was opened for the screw breakage.As reported: "patient called stating he had a shoulder replacement in (b)(6) 2021.In (b)(6) 2022, a revision was needed due to a broken screw.In (b)(6) of 2022, a total shoulder revision was needed because the shoulder 'came apart/ shifted.".
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 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
This is a legal case being reported.This product inquiry is for the revision surgery due to implants 'coming apart/ shifting' in (b)(6) 2022.Another product inquiry was opened for the screw breakage.As reported: "patient called stating he had a shoulder replacement in august 2021.In (b)(6) 2022, a revision was needed due to a broken screw.In (b)(6) 2022, a total shoulder revision was needed because the shoulder 'came apart/ shifted.".

• Brand Name: REUNION TSA - PRESS-FIT HUMERAL STEM 12MM
• 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 ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17969719
• Report Number: 0008031020-2023-00368
• Device Sequence Number: 15153409
• Product Code: KWS
• UDI-Device Identifier: 07613327098150
• UDI-Public: 07613327098150
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 08/09/2025
• Device Catalogue Number: 5569-P-2012
• Device Lot Number: 8J1447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2020
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 132 KG