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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately four years post-implantation, the patient underwent a hip revision due to recurrent dislocations.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat#00877503603 lot#3044439 bioloxâ® delta, ceramic femoral head.G2: foreign ¿ australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} visual examination of the provided pictures identified the explanted liner with deformation to the locking feature and around the outer edges.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the left hip demonstrate a left total hip arthroplasty without hardware failure or loosening.No bony fracture.Osteopenia.Possible oversized femoral head.The root cause of the reported issue is attributed to patient noncompliance.It was reported that the patient suffered multiple dislocations, the first being a year post-surgery where each time the patient had been doing an activity involving extreme range of movement.As per ifu, it states under 'lifestyle habits and considerations' that "premature failure of implants by loosening, fracture, dislocation, subluxation, and/or wear are more likely to occur where patients have unrealistic functional expectations (and conduct excessive, unusual and/or awkward movement and/or activity), are overweight or excessively overweight, or where patients fail to follow through with the required rehabilitation program.The surgeon should inform the patient of postoperative restrictions, the acceptable level of physical activity that can be performed, and how their lifestyle may be impacted" a summary of the investigation was sent to the complainant conveying proper use of the device.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.
Event or Problem Description
No further information at the time of this report.

• Brand Name: G7 ACETABULAR LINER
• Common Device Name: PROSTHESIS, HIP
• 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: 20344354
• Report Number: 0001825034-2024-02300
• Device Sequence Number: 20819571
• Product Code: PBI
• UDI-Device Identifier: 00880304526419
• UDI-Public: (01)00880304526419(17)250210(10)6744987
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Expiration Date: 02/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 010000856
• Device Lot Number: 6744987
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female