MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X25 ST; PROSTHESIS, SCREW

Catalog Number	180552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was implanted with a shoulder arthroplasty.Subsequently, the patient was revised due dislocation.It was noted that 2 screws were also revised due to unkowns reasons.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
(b)(4).D10: comp rvrs shldr glnsp std 36mm cat#115310 lot#j7777247.Comp lk scr 3.5hex 4.75x25 st cat#180552 lot# 66783812.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP LK SCR 3.5HEX 4.75X25 ST
• Common Device Name: PROSTHESIS, SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22586248
• Report Number: 0001825034-2025-02215
• Device Sequence Number: 4540146
• Product Code: PHX
• UDI-Device Identifier: 00880304677159
• UDI-Public: (01)00880304677159(17)340619(10)66794981
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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: 180552
• Device Lot Number: 66794981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female