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U.S. Department of Health and Human Services

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

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STRYKER GMBH REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 44X16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
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.
 
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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 Key10525159
MDR Text Key206770530
Report Number0008031020-2020-02227
Device Sequence Number1
Product Code KWS
UDI-Device Identifier07613327097900
UDI-Public07613327097900
Combination Product (y/n)N
PMA/PMN Number
K103835
Number of Events Reported1
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 Date08/31/2018
Device Model Number5552-E-4416
Device Catalogue Number5552-E-4416
Device Lot NumberMMLDD3
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/18/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received10/22/2020
Supplement Dates FDA Received11/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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