MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E; PROSTHESIS, HIP

Catalog Number	110010244
Medical Device Problem Codes	Separation Failure (2547); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D11: biomet g7 3.5 mm hex screwdriver.Unknown part/lot/serial.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the shell and manhole cover (cover that comes off in order to place screws) would not separate.After attempts to disengage them, the manhole cover was stripped, and the shell became unusable.Another shell was used.No adverse events have been reported as a result of the malfunction.No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified only 1 of 3 low profile plugs were returned with the shell, no apical plug was returned either.The 1 low profile plug was returned still threaded into the shell; the hex of the plug is visually stripped.No other damage was noted during visual evaluation.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 will be filed accordingly.Zimmer biomet will continue to monitor trends.
Event or Problem Description
No additional information available for the reported event.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• Common Device Name: PROSTHESIS, HIP
• 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: 22236194
• Report Number: 0001825034-2025-01759
• Device Sequence Number: 8019373
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)350212(10)67119303
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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
• Device Catalogue Number: 110010244
• Device Lot Number: 67119303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Female