MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X20 ST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	180551
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).H10 narrative: item #: 115396.Lot #: 66483881.Item name: comp rvs cntrl 6.5x30mm st/rst.Item #: 110027734.Lot #: 66671479.Item name: compr vrs glen pps min tpr adr.Item #: 180550.Lot #: 66591620.Item name: comp lk scr 3.5hex 4.75x15 st.Item #: 180553.Lot #: 66021358.Item name: comp lk scr 3.5hex 4.75x30 st.Item #: 180553.Lot #: 66591676.Item name: comp lk scr 3.5hex 4.75x30 st.Item # :180554.Lot #: 66313688.Item name: comp lk scr 3.5hex 4.75x35 st.Item #: 180555.Lot #: 654040.Item name: comp lk scr 3.5hex.4.75x40 st.The product will not be evaluated by zimmer biomet as it was discarded by the hospital.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that the patient underwent a left shoulder arthroplasty.Subsequently, the patient was considered for a pmi product and revised due to loosening and instability of the implant.During the revision, it was noted that the central screw was fractured.All components were removed and replaced; however, a piece of the fractured central screw could not be removed as it was retained in the glenoid.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right shoulder demonstrate a reverse total shoulder arthroplasty with two separate screw fragments within the glenoid and a fractured central and possibly anterior screw.No bony fracture.A definitive root cause cannot be determined.The reported event is confirmed as x-rays were provided.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 4.75X20 ST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22101936
• Report Number: 0001825034-2025-01514
• Device Sequence Number: 7276522
• Product Code: PHX
• UDI-Device Identifier: 00880304677142
• UDI-Public: (01)00880304677142(17)340311(10)66602913
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130390
• 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,Followup
• Report Date (Section B): 07/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 180551
• Device Lot Number: 66602913
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female