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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 01/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign: china.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the acetabular instrument was first polished to the appropriate size and the 48mmc acetabular cup was punched in by the cup inserter along with the 32c high-sided e1 polyethylene liner correctly.The liner would not assemble the mating cup properly and was easily removed and replaced with a 32c ceramic liner.There was a 40 minute delay to get the new liner.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h3 h6 h10 visual examination of the returned product identified there is some damage to the locking feature along with indentations to the area near the scallops.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: G7 HI-WALL E1 LINER 32MM C
• 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: 16271725
• MDR Text Key: 309295613
• Report Number: 0001825034-2023-00195
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527010
• UDI-Public: (01)00880304527010(17)250218(10)6747553
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• 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: 010000925
• Device Lot Number: 6747553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• 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: 02/18/2020
• 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 ACETABULAR CUP
• Patient Sex: Female