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

Catalog Number	010000999
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Joint Laxity (4526); Joint Impingement (4834)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 650-1058 lot: 3220030 cer bioloxd option hd 40mm.Cat: 30154009 lot: 64914939 40mm i.D.Size i +5mm offset liner.Cat: 650-1067 lot: 3183289 cer option type 1 tpr sleve +3.Cat: 00625006520 lot: j7845132 bone screw self-tapping.Cat: 00625006520 lot: 65800522 bone screw self-tapping.Cat: 00625006520 lot: j7562756 bone screw self-tapping.Cat: 00625006520 lot: j7310870 bone screw self-tapping.Cat: 00625006530 lot: j7448940 bone screw self-tapping.Cat: 00625006515 lot: j7884437 bone screw self-tapping.Cat: 00625006540 lot: 64973207 bone screw self-tapping.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 approximately four months post-implantation, the patient underwent a hip revision due to instability, recurrent dislocations, and impingement from poor positioning of implants.The surgeon attributed the recurrent dislocation to poor cup placement.The trochanteric claw had anterior fixation resulting in tissue impingement.During the revision, a competitor cup was cemented into the existing cup; the head and liner were exchanged; and the stem and claw were retained with some tissue around the greater trochanter debrided.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: g3; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were provided.Review of the available records identified the following: patient visited emergency department due to pain in left hip and dislocation of prosthesis.Patient reports hyperflexed internally rotated adducted position on hip, then dislocated posteriorly.¿ reduced in the er.Still using knee brace to keep leg from rotating.Cautioned to adhere to precautions.Plan for revision if another episode of instability occurs.X-ray shows hardware in stable alignment, gt fracture in stable alignment as well, no escape from the claw plate, cup in stable alignment though vertical, screws in stable alignment, stems in stable alignment and slight varus.Patient visited emergency department due to pain in left hip and dislocation of prosthesis.Patient dislocated 3 times and has increasing issues with posterior instability.X-ray shows modular fluted taper stem in place, greater trochanteric claw in place and stable, cup in position, which is vertical and under anteverted, proud screws in the pelvis ¿however this is essentially abutting the medial aspect of the pelvis.¿ significant mild bone loss around this component from prior mom components.Revision operative notes: previously had a 1-stage revision however the components were placed in poor position leading to recurrent instability.During the latest revision, the cup was found to be well fixed without significant bone stock medially so the cup was used as an augment and a depuy cemented cup was placed into the cup.Biomet head was placed.Further debridement was done on the anterior aspect of the greater trochanter and anterior soft tissues as they were the main source of impingement anteriorly.Most was due to the prior greater trochanteric fixation being slightly anterior.However, this was stable and so the device was not realigned.No other intraoperative complications were noted.Stable range of motion.Patient is progressing well and had no concerns.X-rays show well fixed implant.It is noted a cemented cup with cementless zb cup.The new cemented cup is in appropriate inclination.No fractures or dislocation seen.A definitive root cause could not be determined.However, the surgeon notes that the acetabular component and claw were poorly positioned with anterior tissues causing impingement as the result of the prior gt fixation being performed slightly anterior.As per ifu, the placement of the components is the surgeon's discretion based on the patient's anatomy.Per ifu, it states under precautions "physicians should consider component malposition, component placement, and the effect on range of motion when using modular heads and extended liners.Malpostioned acetabular components increase the potential for impingement, premature dislocation and revision".A specific ifu reference could not be provided for the claw as product identification was not provided.It was also noted a competitor cup was cemented onto the existing zimmer biomet acetabular shell and used with a competitor liner.Zimmer biomet has not confirmed the compatibility for these combinations of devices.Please note, per the ifu, it states not to use these products for other than labelled indications (no off-label use), " do not use components of the g7 acetabular system with components of any other system or manufacturer, unless authorized by zimmer biomet"."zimmer biomet or its affiliates are not liable for complications and/or failure that may arise from use of the device in circumstances outside of zimmer biomet or its affiliates control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique." complaint is 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 is available at the time of this report.

• Brand Name: G7 ACETABULAR SCREW
• 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: 24511740
• Report Number: 0001825034-2026-00494
• Device Sequence Number: 10440312
• Product Code: PBI
• UDI-Device Identifier: 00880304527478
• UDI-Public: (01)00880304527478(17)320916(10)7329339
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 010000999
• Device Lot Number: 7329339
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic