MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - PRESS-FIT HUMERAL STEM 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5569-P-2008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Implant Pain (4561)
Date of Event	06/03/2019
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 at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported that the patient had her left shoulder replaced on or about (b)(6) 2014 due to osteoarthritis.It is alleged that this resulted in pain in the shoulder and surrounding regions, loss of range of motion and a fracture of the components.It is further alleged that the patient was revised on (b)(6) 2019 and during the surgery the surgeon found the polyethylene glenoid to be completely fractured down the middle.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event such as x-rays, patient activity levels, and 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 had her left shoulder replaced on or about (b)(6) 2014 due to osteoarthritis.It is alleged that this resulted in pain in the shoulder and surrounding regions, loss of range of motion and a fracture of the components.It is further alleged that the patient was revised on (b)(6) 2019 and during the surgery the surgeon found the polyethylene glenoid to be completely fractured down the middle.

• Brand Name: REUNION TSA - PRESS-FIT HUMERAL STEM 8MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10525150
• Report Number: 0008031020-2020-02226
• Device Sequence Number: 3154881
• Product Code: KWS
• UDI-Device Identifier: 07613327098099
• UDI-Public: 07613327098099
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: 5569-P-2008
• Device Catalogue Number: 5569-P-2008
• Device Lot Number: MLHP75
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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