MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SYSTEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884); Joint Dislocation (2374); Tissue Breakdown (2681)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two weeks post-implantation, the patient underwent a hip revision due to dislocation.During the procedure, a large hematoma was evacuated and minimal necrotic tissue was noted.The intention of the surgery was to allow for cup ingrowth to the bone and then will return to surgery for final cemented stem and constrained liner.The stem and head were explanted without complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat: 00877704002 lot: 2980145 bioloxâ® option, head.Cat: 0106010304 lot: 3168933 avenirâ®, stem.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.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.Medical records were reviewed by a health care professional: it was reported the patient underwent an initial right hemi-hip and was revised due to multiple dislocations and maintained the hemi-hip, however underwent a second revision on due to continued dislocations and was converted to a total hip.The patient then lost balance and fell reaching for toilet paper resulting in a dislocation and was then revised a third time.A definitive root cause cannot be determined.It was reported the patient lost balance and fell reaching for toilet paper, however the patient has a history of dislocations.No problem was found with the device in relation to the hematoma after review by a hcp.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 ACETABULAR SYSTEM
• 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: 20665622
• Report Number: 0001822565-2024-03552
• Device Sequence Number: 20885040
• Product Code: LPH
• UDI-Device Identifier: 00889024520554
• UDI-Public: (01)00889024520554(17)290622(10)66760591
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/12/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 30124007
• Device Lot Number: 66760591
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 61 KG