MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 24MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-4524
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2021
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
As reported: "the patient returned to dr.'s office for a follow-up.Upon examining x-rays it was obvious that peripheral screws had migrated through the baseplate requiring revision surgery.".
Additional Manufacturer Narrative
The reported event could be confirmed, since x-rays and the device were returned.The visual inspection of the device showed that : the baseplate shows some deformation on the lips that bite into the screws at the level of the peripheral holes.The returned peripheral screw and central screw do not show any locking thread deformation.A dimensional inspection was performed, and the peripheral screw holes were measured and were found to be larger than in the drawing.The screw holes also show a deformation of the material on the lip that bites into the screw.As a summary, the peripheral screw holes of the baseplate were badly enlarged, probably during the drilling phase of the operation.The diameter of the lip that holds into the screw should be 0.209 inches according to the drawing, but was found to be between 0.233 inches and 0.2373 inches.This deformation could easily explain the migration of the screws reported.The screws are not the root cause of the migration.Based on investigation, the root cause was attributed to the enlargement of the screw holes of the baseplate, most probably during the insertion of the screws.A review of the device history for the reported lot did not indicate any abnormalities.The size of the peripheral screw holes is checked at a rate of 100% with a go/no go pin during manufacturing.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 complaint report will be updated.
Event or Problem Description
As reported: "the patient returned to dr.'s office for a follow-up.Upon examining x-rays it was obvious that peripheral screws had migrated through the baseplate requiring revision surgery.".

• Brand Name: 4.5MM PERIPHERAL SCREW - 24MM
• 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: 11368863
• Report Number: 0008031020-2021-00049
• Device Sequence Number: 837837
• Product Code: KWS
• UDI-Device Identifier: 07613327098730
• UDI-Public: 07613327098730
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Expiration Date: 04/30/2024
• Device Model Number: 5572-4524
• Device Catalogue Number: 5572-4524
• Device Lot Number: JH5A8K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 05/25/2021
• 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: 71 YR
• Patient Weight: 68