MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM C; PROTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: cat# 010000661 lot# 7450848 g7 pps ltd acet shell 48c; g2: 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 -2024-00678.

Event Description

It was reported that during a right hip replacement surgery, the surgeon polished the acetabulum according to the routine operation.A 48mm c acetabular cup was selected for implantation, with a 32mm c liner.The liner was unable to fit into the acetabular cup.After several unsuccessful attempts, the surgeon chose to implant a larger acetabular cup and liner.There was an approximate 35-minute delay.No additional information available.

Event Description

Additional information received.Although it was initially reported that a larger cup and liner were implanted, it was since determined that the larger cup and liner were not actually used.Instead, the cup and liner that would not lock were soaked in cold water for 10-minutes, and then the products were successfully implanted.There was not a 35-minute delay as initially reported, there was actually a 15-minute delay due to the soak.No additional information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: G7 HI-WALL E1 LINER 32MM C
• Type of Device: PROTHESIS, 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: 18877498
• MDR Text Key: 337359040
• Report Number: 0001825034-2024-00679
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527010
• UDI-Public: (01)00880304527010(17)271005(10)7360776
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 010000925
• Device Lot Number: 7360776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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: 70 YR
• Patient Sex: Female