MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DM PROV LINER 44MM F; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	110024732
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: g7 dm prov liner 42mm e; item # 110024731; lot # 495920.G2, foreign: canada.Visual examination of the returned product identified both devices were returned with gouges, scratches, and indentations from previous uses.Rim and center holes are damaged.The area of the center hole that retains the screws for both provisionals are deformed.Both provisional screws were returned detached.Screws are gouged and the hex show signs of uses.Measurements were within specification.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that, at the start of surgery, scribed nurse rearranged provisional liners in g7 dm tray because they were mixed up, and the screws of the liner e and liner f fell out on table.Surgery was not delayed since we did not use these sizes.No screws fell into patient because it was realized before opening.Investigation of the reported devices later found wear damage present on both devices.Diligence is completed and all available information has been provided at this time.

• Brand Name: G7 DM PROV LINER 44MM F
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 24366918
• Report Number: 0001825034-2026-00368
• Device Sequence Number: 20162345
• Product Code: LPH
• UDI-Device Identifier: 00880304712881
• UDI-Public: (01)00880304712881(11)210412(10)295140
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110024732
• Device Lot Number: 295140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• 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: 02/16/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown