MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 Longevity; Prosthesis, Hip

Catalog Number	20103604
Medical Device Problem Codes	Difficult to Insert (1316); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial hip procedure, the liner could not be implanted properly after multiple attempts.When implanted, the liner was not aligned with the edge of the cup and it appeared crooked.Repeated attempts to implant the liner failed to resolve the issue, resulting in loosening of the acetabular cup.It was decided to remove the liner.An attempt to remove the liner with instruments was unsuccessful.A threaded wrench was used to remove the liner.Two screws were implanted to stabilize the cup and a new liner was successfully implanted.There was a 20 minute delay.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 010000662, lot# 7802579, g7 pps ltd acet shell 50d.G2: foreign ¿ event occurred in china.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: G7 Longevity
• 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 ; +1(574)526-0384
• MDR Report Key: 50191961
• Report Number: 0001822565-2026-02800
• Device Sequence Number: 12292661
• Product Code: LPH
• UDI-Device Identifier: 00889024518735
• UDI-Public: (01)00889024518735(17)290311(10)66555433
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 20103604
• Device Lot Number: 66555433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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
• Patient Sex: Unknown