MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - SR STANDAR D HUMERAL HEAD 44X19; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5552-S-4419
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/27/2018
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.
Event or Problem Description
It was reported that a stage 1 revision was performed on patient's left shoulder due to infection (reported by surgeon, unknown if clinically confirmed, unknown if infecting microorgansim was identified).Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
Additional Manufacturer Narrative
The reported event that reunion tsa - sr standar d humeral head 44x19 was alleged of 'infection' could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.Furthermore, the filling of stryker infection complaints checklist would have been necessary in order to find the exact root cause, but was not possible according to the hospital's internal policy no deviation was found in the packaging & sterilization processes.The items were documented fautless prior to distribution.In addition, the expiration date of all reported products was not exceeded.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.
Event or Problem Description
It was reported that a stage 1 revision was performed on patient's left shoulder due to infection (reported by surgeon, unknown if clinically confirmed, unknown if infecting microorgansim was identified).Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

• Brand Name: REUNION TSA - SR STANDAR D HUMERAL HEAD 44X19
• 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: 7539088
• Report Number: 0008031020-2018-00392
• Device Sequence Number: 2481985
• Product Code: KWS
• UDI-Device Identifier: 07613327097771
• UDI-Public: 07613327097771
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 01/01/2018
• Device Catalogue Number: 5552-S-4419
• Device Lot Number: MMAJE8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: 57 YR
• Patient Weight: 91