MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 46MM G; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 110010247 g7 osseoti 4 hole shell 58mm g 67035482.110031013 28mm i.D.46mm o.D.Size g bearing 67051331.010001002 g7 screw 6.5mm x 45mm 6514808.00625006530 bone screw self-tapping 6.5 mm dia.30 mm length 66673233.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had an initial left tha with depuy implants.Patient had a revision surgery.Patient reported icd coding corresponding to broken internal left hip prosthesis as an indication for revision.The depuy stem was retained, all other components of depuy (shell, liner and head) were revised.Zimmer biomet g7 shell, liner, bearing and screws were implanted, along with a depuy biolox head.No operative notes provided of the initial or revision surgery.Patient reported via a phone call to zb representative that they received mixed implants with zb and depuy components.The patient has significant nerve damage post-op.No medical records are provided related to the issue.A definitive root cause cannot be determined.However, an off-label use was identified as zb implants were used in conjunction with competitor products.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.Please note per the ifu it states "do not use components of the g7 acetabular system with components of any other system or manufacturer, unless authorized by zimmer biomet." and " 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." 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 trends.
Event or Problem Description
It was reported a patient had an initial left total hip arthroplasty with competitor products followed by a revision for an unknown implant failure.During the procedure, the competitor stem was retained, and all other products were revised.The patient is now reporting significant nerve damage.No further information has been provided.
Event or Problem Description
No additional event information.
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, h6, h11.Corrected: d4 (udi #).The reported event could not be confirmed due to lack of product/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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had an initial left tha on (b)(6) 2024 with depuy implants.Patient had a revision surgery on (b)(6) 2024.Patient reported icd coding corresponding to broken internal left hip prosthesis as an indication for revision.The depuy stem was retained, all other components of depuy (shell, liner and head) were revised.Zimmer biomet g7 shell, liner, bearing and screws were implanted, along with a depuy biolox head.No operative notes provided of the initial or revision surgery.Patient reported via a phone call to zb representative that they received mixed implants with zb and depuy components.The patient has significant nerve damage post-op.No medical records provided related to the issue.A definitive root cause cannot be determined.However, an off-label use was identified as zb implants were used in conjunction with competitor products.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.Please note per the ifu, it states "do not use components of the g7 acetabular system with components of any other system or manufacturer, unless authorized by zimmer biomet." and " 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." 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.

• Brand Name: G7 DUAL MOBILITY LINER 46MM G
• 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: 23568129
• Report Number: 0001825034-2025-03643
• Device Sequence Number: 9924668
• Product Code: LPH
• UDI-Device Identifier: 00880304703537
• UDI-Public: (01)00880304703537(17)340401(10)66664855
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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 Model Number: N/A
• Device Catalogue Number: 110024465
• Device Lot Number: 66664855
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: Other
• Patient Sex: Male