MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS, HIP

Catalog Number 010000665

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 follow-up mdr will be submitted.

Event Description

It was reported that during an initial procedure, the middle screw was unable to be removed from the new shell.Upon visual inspection, the shell looked to be stripped in this area.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4), this follow-up report is being submitted to relay additional information.Upon visual inspection the remaining plug has been stripped and could not be removed.Complaint is confirmed.Dhr was reviewed and no device discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to a manufacturing issue.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 Description

No additional event information to report at this time.

• Brand Name: G7 PPS LTD ACET SHELL 56F
• Type of Device: 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: 17107375
• MDR Text Key: 317167599
• Report Number: 0001825034-2023-01315
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: (01)00880304524248(17)330123(10)7420296
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000665
• Device Lot Number: 7420296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1