MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR MONOBLOCK SHELL INSRTR; PROSTHESIS, HIP

Catalog Number	110003450
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product: g7 pps ltd acet shell 52e: catalog#010000663, lot#j7880272.G2: foreign: germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total hip arthroplasty, the insertion instrument was unable to be unscrewed from the acetabular shell.The cup was removed from the surgical site using an additional instrument and a new cup was successfully implanted.There was a thirty (30) minute surgical delay as a result of the malfunction however no patient impact has been reported.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d4; g3; h2; h4; h11.The product is in process of being returned to zimmer biomet for investigation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a2; b4; b5; d4; d9; g3; h2; h3; h6; h11.Visual examination of the returned product identified the shell threads on and off the inserter without resistance.The lead thread of the inserter visually appears rolled.There are gouges along the shaft of the inserter.There are scratches present on the end of the strike plate.The shell has gouges, nicks, and scratches present on the top flat rim surface and within the i.D.No other damage was noted during visual evaluation.No thread gauges were used to verify threads on either device due to damage.The inserter device has an approximate field age of 5 months.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the medical records confirmed the reported event of the inserter not being able to be detached from the cup.The procedure was completed without further complication or events.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records and device evaluation.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 further event information at time of this report.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• 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: 22885594
• Report Number: 0001825034-2025-02673
• Device Sequence Number: 4849432
• Product Code: PBI
• UDI-Device Identifier: 00887868462481
• UDI-Public: (01)00887868462481(11)250310(10)67212393
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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 Catalogue Number: 110003450
• Device Lot Number: 67212393
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 01/23/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/05/2025; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 96 KG