MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 16MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5572-4516
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Revision of left shoulder due to pain and a halo behind the baseplate.
Additional Manufacturer Narrative
Correction: please see d2a & d2b, g1 manufacturing site for devices.The reported event could be confirmed since the device was returned for evaluation but without medical records alleged event could not be confirmed.The returned devices were visually inspected.The peripheral screws and the center screw were found to be in good condition.Examination of the baseplate and glenosphere revealed that they were not centrally aligned; scratch marks on one side of the glenosphere indicate increased contact on that side, confirming misalignment.The screw holes of the baseplate showed damage and deformation, suggesting the screws rubbed against the holes during insertion.The humeral insert and humeral cup were found assembled, with a slight gap visible between their surfaces.The insert displayed uneven wear, indicating improper load transfer from the glenosphere to the insert.Uniform scratch marks were also observed on the humeral cup, which may have resulted from insertion or explantation.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.Based on the investigation, the pain may be associated with a misaligned glenosphere and baseplate; however, this and loosening cannot be confirmed without reviewing the patient¿s medical records, which are required to determine the root cause of the alleged event if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Revision of left shoulder due to pain and a halo behind the baseplate.

• Brand Name: 4.5MM PERIPHERAL SCREW - 16MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; postfach; mahwah NJ 07430
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23155460
• Report Number: 0008031020-2025-01645
• Device Sequence Number: 13300655
• Product Code: KWS
• UDI-Device Identifier: 07613327098716
• UDI-Public: 07613327098716
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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 Catalogue Number: 5572-4516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female