MAUDE Adverse Event Report: STRYKER GMBH 6.5MM CENTER SCREW - 32M M; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5573-6532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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.".
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
This device is concomitant and did not contribute to the reported failure.Indeed the central screw did not migrate and the central screw hole of the baseplate did not show any deformation.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: 6.5MM CENTER SCREW - 32M M
• 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: 11368762
• Report Number: 0008031020-2021-00045
• Device Sequence Number: 16353138
• Product Code: KWS
• UDI-Device Identifier: 07613327098839
• UDI-Public: 07613327098839
• 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): 05/26/2021

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: 09/30/2023
• Device Model Number: 5573-6532
• Device Catalogue Number: 5573-6532
• Device Lot Number: TX29NW
• 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: 05/26/2021
• 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