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

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 05/06/2023

Event Type  malfunction  

Event Description

It was reported that during acetabular cup implantation, the tool and the prosthesis could not be separated, and the separation process resulted in the tool breaking.Nothing fell into the patient and procedure was completed using another device.

Manufacturer Narrative

(b)(4).G2: foreign: china.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01110.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.H3: device in process to return.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified there is scuffing to the inner radius and the center hole threads of the device.There is gouging around one of the plug holes.Complaint confirmed based on evaluation of returned shell.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event medical records were not provided.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 56F
• Type of Device: PROSTHETIC, 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: 16948183
• MDR Text Key: 315423738
• Report Number: 0001825034-2023-01109
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: (01)00880304524248(17)321003(10)7340197
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: 010000665
• Device Lot Number: 7340197
• 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: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSERTER
• Patient Sex: Male
• Patient Weight: 65 KG