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

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that the threads of the g7 cup inserter were found damaged.This was detected before the case started.There was no patient involvement or impact.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d4; g3; h2; h3; h4; h6.Visual examination of the returned product identified the thread on the tip has separated from the device but remains attached.There are impact marks on the strike plate and scuffing along the shaft.The complaint is confirmed based on the evaluation of the returned product.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 even information to report at this time.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• 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: 19070557
• Report Number: 0001825034-2024-00971
• Device Sequence Number: 19998175
• Product Code: PBI
• UDI-Device Identifier: 00887868462481
• UDI-Public: (01)00887868462481(11)230914(10)86206094
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 110003450
• Device Lot Number: 66206094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown