MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR LINER 10 DEG E1 LINER 32MM C; PROSTHESIS, HIP

Catalog Number	010000886
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 110010242 lot# 66589774 g7 osseoti 3 hole shell 48mm c.Cat# 00811400010 lot# 65777128 femoral stem 12/14 neck taper ext.Offset size 0 105 mm stem length.Cat# 010000999 lot# 7784803 g7 screw 6.5mm x 30mm.Cat# 00877503202 lot# 3165638 biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 1 month later due to dislocation and instability.During the removal of the head, the stem came loose.All devices were revised and replaced.It was reported 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 {update/corrected} updated: g3; h2; h3; h6 visual examination of the provided pictures identified the explanted liner, head, stem, shell and screw.Devices were covered in bio-debris.No further evaluation could be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be 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
No further information at the time of this report.

• Brand Name: G7 ACETABULAR LINER 10 DEG E1 LINER 32MM C
• 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: 22492707
• Report Number: 0001825034-2025-02053
• Device Sequence Number: 4106510
• Product Code: PBI
• UDI-Device Identifier: 00880304526679
• UDI-Public: (01)00880304526679(17)260511(10)7028117
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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 Expiration Date: 05/11/2026
• Device Catalogue Number: 010000886
• Device Lot Number: 7028117
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG