MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM F; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 a primary hip arthroplasty.Subsequently, the patient was revised for instability and subluxation.The patient had a zb g7 cup and a competitor stem and head insitu.The surgeon explanted the liner and exchanged it for a g7 dual mobility liner and bearing to improve stability.The retained stem had a 12/14 neck taper, so the surgeon opted to explant the competitor head and replace it with a zb 12/14 biolox option femoral head with a taper sleeve to accommodate the stem trunnion.The explanted zb liner had no signs of wear or degradation.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined; however, it is known that a competitor head and stem was used with the zimmer biomet bearing and this is considered off label.It states under compatibility "do not use components of the g7 acetabular system polyethylene acetabular liners with components of any other system or manufacturer, unless authorized by zimmer biomet." it is unknown if this off label use caused or contributed to the reported event.Unable to confirm complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: a4, b7, g3, g6, h2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h11.The reported event could not be confirmed due to lack of product/event information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: the g7 liner was used with a competitor head and stem.The g7 liner was used with a g7 cup, for which the product identifier is unknown.Therefore, compatibility cannot be confirmed.A definitive root cause cannot be determined; however, it is known that a competitor head and stem was used with the zimmer biomet bearing and this is considered off label use per the ifu.It states under compatibility "do not use components of the g7 acetabular system polyethylene acetabular liners with components of any other system or manufacturer, unless authorized by zimmer biomet." it is unknown if this off-label use caused or contributed to the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information.

• Brand Name: G7 HI-WALL E1 LINER 36MM F
• Common Device Name: PROSTHESIS, HIPS
• 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: 21034805
• Report Number: 0001825034-2024-03056
• Device Sequence Number: 11792320
• Product Code: PBI
• UDI-Device Identifier: 00880304527119
• UDI-Public: (01)00880304527119(17)250810(10)6839504
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/30/2026

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 Expiration Date: 08/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 010000936
• Device Lot Number: 6839504
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 03/05/2025; 10/24/2025; 03/26/2026
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/06/2025; 11/14/2025; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2020
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 71 KG