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

Model Number	5572-2800
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient's right reverse shoulder was revised after patient complaint of pain and x-rays showing a peripheral screw loose in the joint.Intra-operatively, it was noted that the peripheral screws had 'windshield wipered' in the joint, etching the glenosphere and passing through the baseplate into the joint.The baseplate, glenosphere and center screw came out all in one piece.
Event or Problem Description
It was reported that the patient's right reverse shoulder was revised after patient complaint of pain and x-rays showing a peripheral screw loose in the joint.Intra-operatively, it was noted that the peripheral screws had 'windshield wipered' in the joint, etching the glenosphere and passing through the baseplate into the joint.The baseplate, glenosphere and center screw came out all in one piece.
Additional Manufacturer Narrative
The reported event could partially be confirmed, based on the state of the implants returned.The pictures provided revealed that the screw holes where the two peripheral screws were inserted have expended, in such a way that the material around it is very damaged.On one side of the baseplate, the screw hole has been damaged so severely that there is hardly any material left on one border.The deformation also makes the determination of the lot number for the baseplate impossible since the material around it disappeared.More detailed information about the complaint event such as the x-rays must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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: BASEPLATE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10864670
• Report Number: 0008031020-2020-02484
• Device Sequence Number: 11478878
• Product Code: KWS
• UDI-Device Identifier: 07613327098709
• UDI-Public: 07613327098709
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 5572-2800
• Device Catalogue Number: 5572-2800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/01/2021
• 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: 70 YR