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

Catalog Number 010000663

Device Problem Difficult to Insert (1316)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

T was reported that during the procedure, the liner would not assemble with the shell.Another liner was used to complete the procedure.There was no impact or health consequences to the patient.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).G2: poland 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

No additional event information to report at this time.

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 their liner locking feature has been deformed and shaved.There is no visible damage to the shell.It is unknow if the damage occurred prior to or during the assembly attempts.Complaint 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02616.D10: cat #: 010000927 / g7 hi-wall e1 liner 32mm e/ lot #: 726140.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

• Brand Name: G7 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: 18083577
• MDR Text Key: 327515298
• Report Number: 0001825034-2023-02616
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)330306(10)7440497
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000663
• Device Lot Number: 7440497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.