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

Model Number	N/A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the surgeon inserted the screw into the cup.When checked intra-operatively, the screw had gone through the cup.The liner was removed and the screw pulled out from inside the cup and then the cup was removed.The surgeon inserted a new cup and screw to complete the procedure.After the procedure, the first screw and cup used were checked again and it was found the screw could be inserted through the first right screw hole if pushed hard enough.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat: 00625006520 lot: j7555005 bone screw self-tapping.G2: foreign ¿ japan.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h4; h6 visual examination of the returned product identified no damage to the outer radius of the shell.The inner radius of the shell had scratches and scuffing around all four holes.One of the low-profile holes an indentation around the lip.The outside diameter of the shell was checked and found within specification.The three low-profile holes were checked and found to be in specification.Review of the device history records 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: screw has been inserted and has passed through the cup into the acetabulum and is not providing cup fixation.A definitive root cause cannot be determined.The complaint is confirmed based on the x-ray findings.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 is available at the time of this report.

• Brand Name: G7 ACETABULAR SYSTEM
• 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: 20693584
• Report Number: 0001825034-2024-02694
• Device Sequence Number: 8584915
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)340602(10)66623601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010244
• Device Lot Number: 66623601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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.
• Patient Sex: Unknown