MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 CURVED ACETABULAR SHELL INSERTER; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Codes	Separation Failure (2547); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat#110003454, lot#unk g7 curved inserter thd shaft.Cat#110010241, lot#66577630 g7 osseoti 3 hole shell 46mm b.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.
Event or Problem Description
It was reported that when inserting the cup, the inserter threads were deformed, and it could not be removed.The threaded shaft in the inserter appears damaged, but unable to confirm as the pieces were unable to be separated later.Another cup was used to complete the procedure and there was a 16-30 minute delay.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).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2; h3; h4; h6.Visual examination of the returned product/provided pictures identified the inserter is stuck inside of the shell.The hex of the threaded shaft is damaged and could not be removed to separate the inserter and shell for further review.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Based on the product review, the complaint is confirmed.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 CURVED ACETABULAR SHELL INSERTER
• Common Device Name: INSTRUMENT, 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: 20388906
• Report Number: 0001825034-2024-02351
• Device Sequence Number: 15069152
• Product Code: PBI
• UDI-Device Identifier: 00887868462511
• UDI-Public: (01)00887868462511(11)240401(10)66667357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121874
• 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): 02/06/2025

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: 110003453
• Device Lot Number: 66667357
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown