MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E NEUTRAL LNR 36MM D; PROSTHESIS, HIP

Catalog Number	30103604
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip revision approximately one-year post implantation due to the liner¿s locking mechanism failing.The liner was revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: ig7 osseoti multihole acet she ll 50mm d.Item: 1100102631.Lot: 67269038.Bioloxâ® delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14.Item: 00877503601.Lot: 3232920.Bone screw self-tapping 6.5 mm dia.20 mm length.Item: 00625006520.Lot: j7941442.G2: foreign ¿ japan.The customer indicated that the product was discarded; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: G7 VIT E NEUTRAL LNR 36MM D
• 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: 24547669
• Report Number: 0001822565-2026-00761
• Device Sequence Number: 12184756
• Product Code: LPH
• UDI-Device Identifier: 00889024519893
• UDI-Public: (01)00889024519893(17)300401(10)67260377
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 06/30/2026

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 Catalogue Number: 30103604
• Device Lot Number: 67260377
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown