MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5572-2800
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/27/2018
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 reverse shoulder was revised due to disassociation of the glenosphere from the baseplate.Surgeon reported a possible cause/ contributor of possible soft tissue in the morris taper.Patient was revised to a construct of the same catalog numbers.Rep reported that no further information is available due to hospital policy.
Event or Problem Description
It was reported that the patient's left reverse shoulder was revised due to disassociation of the glenosphere from the baseplate.Surgeon reported a possible cause/ contributor of possible soft tissue in the morris taper.Patient was revised to a construct of the same catalog numbers.Rep reported that no further information is available due to hospital policy.
Additional Manufacturer Narrative
The reported event that baseplate was alleged of 'disassociation' could not be confirmed, since the returned device is conforming to specifications and fully functional and no x-rays confirming the reported event were provided.More detailed information about the complaint event such as postoperative x-rays and ct-scans must be available in order to determine the exact root cause of the complaint event.However, based on the event description, the presence of soft tissues between the two components could have hindered their connection.As a reminder, the operative technique clearly reminds the user to make sure that the modular components are firmly mated to prevent disassociation.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 any further information is provided, the investigation report will be updated.

• Brand Name: BASEPLATE
• 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: 8250937
• Report Number: 0008031020-2019-00028
• Device Sequence Number: 2124693
• Product Code: KWS
• UDI-Device Identifier: 07613327098709
• UDI-Public: 07613327098709
• 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: 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): 03/07/2019

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: 06/30/2023
• Device Catalogue Number: 5572-2800
• Device Lot Number: 486MLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/07/2019
• 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: 75 YR