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

Catalog Number	30124006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Bursitis (4832)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two years post-implantation, the patient underwent a hip revision due to severe pain and failed implants.Patient experienced pain, weakness, trochanteric bursitis, and possible iliopsoas tendinitis.The shell was retained and all other implants revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat: 650-1058, lot: 3111577, cer bioloxd option hd.Cat: 650-1066, lot: 3111783, cer opt type 1 tpr sleve.Cat: 110010246, lot: 65273587, g7 osseoti 4 hole shell.Cat: 51-149080, lot: 7148678, tprlc xr mp fp t1 pps.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and review of the available records identified the following: patient had an initial tha and began experiencing pain and weakness with resisted right hip flexion sitting at 90 degrees.Bursitis and iliopsoas tendinitis noted and relief with injection.Pain along right groin.Patient had a revision due to failed implants and severe pain.Iliopsoas tenotomy noted.Cup was well fixed and no loosening observed.Liner, stem and head were explanted.No other complications noted.A definitive root cause cannot be determined based on the medical records, the 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.

• Brand Name: G7 VIVACIT-E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22183029
• Report Number: 0001822565-2025-01815
• Device Sequence Number: 20958784
• Product Code: LPH
• UDI-Device Identifier: 00889024520547
• UDI-Public: (01)00889024520547(17)270316(10)65323993
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 30124006
• Device Lot Number: 65323993
• 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: 02/08/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White