MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM E; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 110017103 g7 finned 3 hole shell 52e 6401769.51-101100 tprlc 133 fp type1 pps ho 10.0 6180882.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 an initial right total hip arthroplasty completed.The patient presented for an office visit due to severe right inguinal pain.The patient reported to have started pilates and new exercises.X-rays showed the implants were in satisfactory position without complications.The patient was diagnosed with hip flexor tendonitis, instructed to limit pilates for 2 weeks, and was prescribed an oral steroid dose pack.The patient did well until the patient reported to the care team of worsening groin pain along with difficulty raising leg.The patient was given an ultrasound and fluoroscopically guided right psoas bursa injection.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional 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.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right total hip arthroscopy was performed approximately 6 years ago.Subsequently, approximately 4 years post implantation, at a follow up, the patient presented with pain.The x-rays showed no abnormalities.The pain continued to worsen, so a bursa injection was performed a year later.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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 NEUTRAL E1 LINER 36MM E
• 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: 21433528
• Report Number: 0001825034-2025-00420
• Device Sequence Number: 4528577
• Product Code: PBI
• UDI-Device Identifier: 00880304526426
• UDI-Public: (01)00880304526426(17)240102(10)6453164
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: Lay User/Patient
• Device Expiration Date: 01/02/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000857
• Device Lot Number: 6453164
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 83 KG