MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - X3 PEGGED GLENOID - SIZE 48; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5542-P-0048
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that reunion tsa - x3 pegged glenoid - size 48 was alleged of 'revision' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.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.Retained by hospital.
Event or Problem Description
It was reported that patient's right shoulder was revised due to glenoid loosening (cause of or contributors to loosening not reported).Patient was revised to a keeled glenoid and a 15mm eccentric head.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: REUNION TSA - X3 PEGGED GLENOID - SIZE 48
• 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: 7896022
• Report Number: 0008031020-2018-00619
• Device Sequence Number: 1806838
• Product Code: KWS
• UDI-Device Identifier: 07613327097658
• UDI-Public: 07613327097658
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: 03/01/2022
• Device Catalogue Number: 5542-P-0048
• Device Lot Number: 1K5NE6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/20/2018
• 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: 31 YR
• Patient Weight: 74