MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 44X16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5552-E-4416

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Implant Pain (4561)

Event Date 06/03/2019

Event Type  Injury  

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.Device disposition unknown.

Event 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.

Event 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.

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 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.

• Brand Name: REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 44X16
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10525159
• MDR Text Key: 206770530
• Report Number: 0008031020-2020-02227
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327097900
• UDI-Public: 07613327097900
• Combination Product (y/n): N
• PMA/PMN Number: K103835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 5552-E-4416
• Device Catalogue Number: 5552-E-4416
• Device Lot Number: MMLDD3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention