MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SYSTEM PPS LTD ACET SHELL 52E; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign ¿ china.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00817.The 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 the cup could not be removed from the inserter during surgery.A different cup and inserter were used to complete the procedure.The cup and inserter were later separated.There was a 15 minute delay.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

• Brand Name: G7 ACETABULAR SYSTEM PPS LTD ACET SHELL 52E
• 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: 18970160
• MDR Text Key: 338505153
• Report Number: 0001825034-2024-00816
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)330915(10)7604143
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000663
• Device Lot Number: 7604143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male