MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - PRESS-FIT HUMERAL STEM 13MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5569-P-2013
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.
Event or Problem Description
It was reported that patient's left shoulder was revised due to the humeral head becoming disassociated from the stem.The stem was reported to have counter-sunk into the patient's humerus.The surgeon stated that no trauma (fall, etc) had been reported by the patient.Patient was revised to a larger stem and same-sized humeral head.
Event or Problem Description
It was reported that patient's left shoulder was revised due to the humeral head becoming disassociated from the stem.The stem was reported to have counter-sunk into the patient's humerus.The surgeon stated that no trauma (fall, etc) had been reported by the patient.Patient was revised to a larger stem and same-sized humeral head.
Additional Manufacturer Narrative
The reported event that reunion tsa - press-fit humeral stem 13mm was alleged of 'additional/revision procedure' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.As rep confirmed no product return and no additional information is available, as risk management does not allow this to be released.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 - PRESS-FIT HUMERAL STEM 13MM
• 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: 7756242
• Report Number: 0008031020-2018-00548
• Device Sequence Number: 11070254
• Product Code: KWS
• UDI-Device Identifier: 07613327098143
• UDI-Public: 07613327098143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 06/01/2023
• Device Catalogue Number: 5569-P-2013
• Device Lot Number: 47TY60
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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: 68 YR