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

Catalog Number	110003450
Medical Device Problem Codes	Difficult to Insert (1316); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ canada customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported, during a case, the nurse had trouble putting final cup on straight handle impactor, to realize, the threads were damaged.Surgery was completed with other handle already on sterile table, no delay.It was confirmed that no further information could be provided.

• 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: 25461672
• Report Number: 0001825034-2026-01701
• Device Sequence Number: 16064778
• Product Code: PBI
• UDI-Device Identifier: 00887868462481
• UDI-Public: (01)00887868462481(11)250306(10)67212297
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 67212297
• Was Device Available for Evaluation?: Yes
• 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: 05/20/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown