MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 12/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign: country: china.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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2023-00100.

Event Description

It was reported that the surgeon followed surgical technique and grinded the acetabulum, used the 47 trial implant, then implanted the acetabular prosthesis 48, which was very stable.The corresponding e1 liner c-32 was then dismantled, the inside of the acetabulum was cleaned, and the liner implanted.It was found that after knocking down, the liner was still in an unstable state.Repeated attempts were made to implant several times, but was still not stable, so the acetabular prosthesis was removed.There were no additional liners of this size available at the facility, and the surgery could not wait for the same size of implant to be delivered.Since the initial liner could not be driven into the acetabular cup, and there were no other alternative liners of the same size available, the patient's acetabulum was continued to be ground, and a larger acetabular cup and liner were used.The acetabular file was increased by one, and the 50th acetabular cup was implanted, along with the corresponding e1 liner, which was very stable after implantation.The surgery was prolonged by 30 minutes.The patient had no other problems at this time, and there were no contributing patient conditions related to the event.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product was returned and evaluated.A visual examination of the returned product identified that the shell is in decent overall condition.Scratching was observed on the inner radius.There was no damage to the scallop cutouts or locking groove.The liner barb was found damaged in two locations.A poly strand protrudes from the barb in one location, and the other location was gouged such that the material was deformed.Scratching and scuffing are also present on the outer radius.The sidewall exhibits multiple tool marks imprinted into the material.Medical records were not provided.The reported products were reviewed for compatibility with no issues noted.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: G7 PPS LTD ACET SHELL 48C
• 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: 16205607
• MDR Text Key: 308740216
• Report Number: 0001825034-2023-00090
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524200
• UDI-Public: (01)00880304524200(17)320228(10)7194718
• 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,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• 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: 010000661
• Device Lot Number: 7194718
• 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: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG