MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 50MM D; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.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 hip arthroplasty.Subsequently, the patient was revised due to malposition of the cup implant by the primary surgeon four (4) years post implantation.The cup was the only implant revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected 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.Medical records were not provided.A definitive root cause cannot be determined.The placement of the implant is the surgeon's discretion based on patient anatomy.While it is alleged it was revised only due to malposition by the primary surgeon, malposition of the implant could not be confirmed.This complaint cannot be confirmed.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 50MM D
• 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: 20453130
• Report Number: 0001825034-2024-02427
• Device Sequence Number: 8616615
• Product Code: LPH
• UDI-Device Identifier: 00887868355875
• UDI-Public: (01)00887868355875(17)300210(10)6736655
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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 Model Number: N/A
• Device Catalogue Number: 110010243
• Device Lot Number: 6736655
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female