MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR LINER HIGH WALL 32MM E; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately sixteen months post implantation, the patient was revised due to pain.There was no reported failure of any implants, but the surgeon noted possible malposition of the shell as contributing.The shell, liner, and head were revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat#: 51-113150, lot#: 6086695, tprlc 133 type1 bm so 15.0.G2: foreign ¿ australia.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.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01127, 0001825034-2024-01129.This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations couldn¿t not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the left hip arthroplasty is anatomically aligned.There is no fracture or dislocation.Bone quality appears osteopenic.The complaint cannot be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.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 additional event information to report at this time.

• Brand Name: G7 ACETABULAR LINER HIGH WALL 32MM E
• 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: 19228850
• Report Number: 0001825034-2024-01128
• Device Sequence Number: 5855732
• Product Code: PBI
• UDI-Device Identifier: 00880304527034
• UDI-Public: (01)00880304527034(17)260212(10)6968586
• 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: 2023
• 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): 07/17/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/12/2026
• Device Model Number: N/A
• Device Catalogue Number: 010000927
• Device Lot Number: 6968586
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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: Male