MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7; PROSTHESIS, HIP

Catalog Number	010000663
Medical Device Problem Codes	Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat: 20123605 lot: 67185304 36mm i.D.Size e high wall liner.Cat: 20123606 lot: 66098514 36mm i.D.Size f high wall liner.E1: phone number: (b)(6).G2: foreign ¿ 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.
Event or Problem Description
It was reported that during a hip procedure, the liner failed to lock with the cup during insertion causing a fracture of the acetabular base.The cup collapsed and became non-functional.The cup was replaced with a larger size with no other intervention for the fracture.The new liner still could not be implanted.The procedure had to be completed using a ceramic liner.There was a 20-minute delay.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5; d9; g3; h2.The product has been received by zimmer biomet and 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 during a hip procedure, the 52 mm failed to seat in the acetabulum.A 54 mm cup was implanted and the poly liner failed to lock with the cup, resulting in a fracture of the acetabulum.A ceramic liner was implanted into the 54 mm cup to complete the procedure with no other intervention for the fracture.There was a 20-minute delay.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.Visual examination of the returned product identified the shell confirms etch identification.Foreign debris is embedded in the porous coating.Inner spherical surface and rim face show scratches from attempted use.No other damage was noted.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty acetabular cup is associated with medially displaced fractures of the acetabulum and medial malposition of the acetabular cup and screws which project into the pelvis.Marked generalized reduced bone mineral density is a risk factor for acetabular fracture during implantation of the acetabular cup.A definitive root cause cannot be determined.Complaint is not 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.

• Brand Name: G7
• 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: 23125014
• Report Number: 0001825034-2025-02982
• Device Sequence Number: 15790926
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)330925(10)7625709
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2026

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: 010000663
• Device Lot Number: 7625709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 02/13/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/04/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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 Age: 69 YR
• Patient Sex: Unknown