MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - PRESS-FIT HUMERAL STEM 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5569-P-2011
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330); Joint Dislocation (2374)
Date of Event	05/23/2023
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 remains implanted in the patient.
Event or Problem Description
It was reported that a patient complained of rubbing and grinding in their arm and the doctor said it would get better.The patient says that their condition has gotten worse.The patient cannot use their arm and/or raise it above their head.Patient wants their arm fixed and is seeking compensation."equipment" has come apart in patient's arm.Patient might need a revision.Ct scan is scheduled to determine if there is enough bone for a revision.Patient cannot work and is on disability.
Additional Manufacturer Narrative
Please note the correction regarding the h6 device code: the reported event that was 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.Due to the lack of evidence and further information it was not possible to determine the root cause of the reported 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 a patient complained of rubbing and grinding in their arm and the doctor said it would get better.The patient says that their condition has gotten worse.The patient cannot use their arm and/or raise it above their head.Patient wants their arm fixed and is seeking compensation."equipment" has come apart in patient's arm.Patient might need a revision.Ct scan is scheduled to determine if there is enough bone for a revision.Patient cannot work and is on disability.

• Brand Name: REUNION TSA - PRESS-FIT HUMERAL STEM 11MM
• 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: 17159103
• Report Number: 0009610622-2023-00202
• Device Sequence Number: 7038918
• Product Code: KWS
• UDI-Device Identifier: 07613327098112
• UDI-Public: 07613327098112
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 5569-P-2011
• Device Catalogue Number: 5569-P-2011
• Device Lot Number: NP3YL3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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: Female
• Patient Weight: 180 KG