MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - SR STANDAR D HUMERAL HEAD 52X17; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5552-S-5217
Health Effect - Clinical Codes	Fall (1848); Tissue Damage (2104)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported that the patient's left shoulder was revised due to disassociation of the head from the stem.Patient did not admit to any trauma, but the surgeon reported that the patient was prone to falling, and noted that there was torn soft tissue at that location.Patient was revised to a reverse shoulder.
Event or Problem Description
It was reported that the patient's left shoulder was revised due to disassociation of the head from the stem.Patient did not admit to any trauma, but the surgeon reported that the patient was prone to falling, and noted that there was torn soft tissue at that location.Patient was revised to a reverse shoulder.
Additional Manufacturer Narrative
The reported event that reunion tsa - sr standar d humeral head 52x17 was alleged of 'disassociation' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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 STANDAR D HUMERAL HEAD 52X17
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8182761
• Report Number: 0008031020-2018-01080
• Device Sequence Number: 19164270
• Product Code: KWS
• UDI-Device Identifier: 07613327097832
• UDI-Public: 07613327097832
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 11/30/2019
• Device Catalogue Number: 5552-S-5217
• Device Lot Number: MNPVN6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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
• Patient Age: 50 YR
• Patient Weight: 101