MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY NEUTRAL 40MM H; PROSTHESIS, HIP

Catalog Number	20104008
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: g7 pps ltd acet shell 62h, item: 010000668, lot: j7867489.G2: foreign, canada.The customer has indicated that the product is not available and will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the surgeon was unable to seat the g7 liner into the g7 shell.A second g7 liner was opened and attempted with the same result.A third g7 liner was then assembled, and the case was completed successfully.Due diligence is complete as multiple attempts were made; however, no further information is available.
Event or Problem Description
It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h6.Visual examination of the returned product identified there is a hole in the liner that visually appears to be from a screw, it starts on the top flat surface and exits through the o.D.There are gouges to the outside tapered surface.Multiple of the anti-rotation scallops are deformed with indentations.The outside locking rim has a burr like material rolled over the edge.The inner diameter has a scratch.No other damage was noted during visual evaluation.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history record 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.

• Brand Name: G7 LONGEVITY NEUTRAL 40MM H
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 23831438
• Report Number: 0001822565-2025-04566
• Device Sequence Number: 21154394
• Product Code: LPH
• UDI-Device Identifier: 00889024518827
• UDI-Public: (01)00889024518827(17)300121(10)67122072
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 20104008
• Device Lot Number: 67122072
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown