MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEU +5MM ARCOMXL LNR 36MM G; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown cup unknown.During the submission of the supplemental report for mdt938460 (0001825034-2025-01820), it was discovered that the report id duplicated that of another submission.Thus this event is being captured on this file as the prior report that was a duplicate, was for another event.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Liner: review of the device history record identified no deviations or anomalies during manufacturing.Liner: 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.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 trends.
Event or Problem Description
It was reported the patient underwent a hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient was revised due to disassociation.The liner disassociated from the cup.The liner and cup were explanted.

• Brand Name: G7 NEU +5MM ARCOMXL LNR 36MM 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: 23019177
• Report Number: 0001825034-2025-02874
• Device Sequence Number: 15962044
• Product Code: LPH
• UDI-Device Identifier: 00880304673212
• UDI-Public: (01)00880304673212(17)230420(10)6279288
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K142882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 04/20/2023
• Device Model Number: N/A
• Device Catalogue Number: 110017187
• Device Lot Number: 6279288
• 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: 09/08/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown