MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 36MM DIA X 4MM THK; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5570-3604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Fluid Discharge (2686)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Hospital retained; sent to pathology per or protocol.
Event or Problem Description
As reported: "[surgeon] reports patient [patient name], a status post right reverse shoulder replacement done approximately 2 months ago now came into the office with a draining open sore at the incision site.[surgeon] decided to wash out and revise the shoulder implants.All implants were carefully removed except the humeral stem which was well fixed.The shoulder washed out extensively and a new set of implants were replaced (baseplate, glenosphere, screw, tray and insert).Surgery was performed without incident.No further information is available due to emr password secured.".
Event or Problem Description
As reported: "[surgeon] reports patient [patient name], a status post right reverse shoulder replacement done approximately 2 months ago now came into the office with a draining open sore at the incision site.[surgeon] decided to wash out and revise the shoulder implants.All implants were carefully removed except the humeral stem which was well fixed.The shoulder washed out extensively and a new set of implants were replaced (baseplate, glenosphere, screw, tray and insert).Surgery was performed without incident.No further information is available due to emr password secured.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event such as x-rays, patient details, patient activity levels 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: HUMERAL CUP - 36MM DIA X 4MM THK
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9993265
• Report Number: 0008031020-2020-01394
• Device Sequence Number: 11851078
• Product Code: KWS
• UDI-Device Identifier: 07613327098365
• UDI-Public: 07613327098365
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: 08/31/2024
• Device Model Number: 5570-3604
• Device Catalogue Number: 5570-3604
• Device Lot Number: HA46L5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 07/14/2020
• 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