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	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 010002726 item name g7 36mm ball impactor lot # zb6660481 010002725 item name g7 32mm ball impactor lot # zb161101 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 impactor threads were damaged which led to damaged monoblock g7 impactor.There is no additional information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 h11 visual examination of the returned product identified the strike plate of the shell inserter handle has indentations to the face and underside.The threads of the device have been damaged.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.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.

• 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: 19679179
• Report Number: 0001825034-2024-01773
• Device Sequence Number: 14232014
• Product Code: PBI
• UDI-Device Identifier: 00887868462481
• UDI-Public: (01)00887868462481(11)230614(10)66063583
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 66063583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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
• Patient Sex: Prefer Not To Disclose