MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - PRESS-FIT HUMERAL STEM 14MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS

Model Number	5569-P-2014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
The used device was returned to stryker with no explanation about why the patient was revised.
Additional Manufacturer Narrative
G1: manufacturing site updated.The reported event could only partially be confirmed, since the device was returned, but no other evidence was provided.The visual inspection of the returned devices shows that: the devices were returned and generally don't present any major deformations.The baseplate has slight deformations on the screw holes and scratches at the flat part of the device.The glenosphere also has scratches on the surface that rubs against the poly.The scratches are not big enough to cause the device to loose its functionality.The poly piece does not show any notable deformations.Finally the stem presents important signs of remaining bone, which proves that the implant was well integrated in the bone.The screws don't show any deformation or signs of wear.More detailed information about the complaint event (such as the x-rays and the reason for the revision) 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 more information is provided, the case will be reassessed.
Event or Problem Description
The used device was returned to stryker with no explanation about why the patient was revised.

• Brand Name: REUNION TSA - PRESS-FIT HUMERAL STEM 14MM
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11925820
• Report Number: 0008031020-2021-00250
• Device Sequence Number: 17121330
• Product Code: KWS
• UDI-Device Identifier: 07613327098167
• UDI-Public: 07613327098167
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 12/31/2021
• Device Model Number: 5569-P-2014
• Device Catalogue Number: 5569-P-2014
• Device Lot Number: K038PD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 08/11/2021
• 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