MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X45 ST; PROSTHESIS, SCREW

Catalog Number	180556
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: compr vrs glen pps min tpr adr cat#: 110027734, lot#: 66277264, comp rvs cntrl 6.5x35mm st/rst cat#: 115397, lot#: 65859220, comp rvs cntrl 6.5x40mm st/rst cat#: 115398, lot#: 426670, comp lk scr 3.5hex 4.75x35 st cat#: 180554, lot#: 483240, comp lk scr 3.5hex 4.75x35 st cat#: 180554, lot#: 483250, comp lk scr 3.5hex 4.75x35 st cat#: 180554, lot#: 905710, comp lk scr 3.5hex 4.75x40 st cat#: 180555, lot#: 631400, comp lk scr 3.5hex 4.75x30 st cat#: 18055,3 lot#: 66033987.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient is being considered for a revision procedure due to glenoid loosening and pain in the shoulder.A custom glenoid is currently being manufactured and the revision procedure is planned to occur approximately 13 months post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: b2, b5, d6b, h6, the following sections were updated: b3, b4, g3, g6, h2, h3, h6, h10, 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 for lots 426670, 483240, and 483250.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event for lots 66277264, 65859220, 905710, 384790, 631400, and 66033987.A definitive root cause cannot be determined.The reported revision is confirmed from the provided revision sticker sheet but the reported loosening 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.
Event or Problem Description
It was further reported that a patient underwent a revision procedure approximately 13 months post implantation due to glenoid loosening and pain in the shoulder.Attempts have been made and additional information on the reported event is unavailable at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMP LK SCR 3.5HEX 4.75X45 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.; 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: 20708610
• Report Number: 0001825034-2024-02720
• Device Sequence Number: 9610117
• Product Code: PHX
• UDI-Device Identifier: 00880304677197
• UDI-Public: (01)00880304677197(17)320523(10)384790
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 01/23/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 180556
• Device Lot Number: 384790
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Male