MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 36MM D; PROSTHESIS, HIP

Model Number 010000895

Device Problem Difficult to Insert (1316)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: g7 osseoti 3 hole shell 50mm d: catalog#110010243, lot#7292173; g7 neutral e1 liner 36mm d: catalog#010000856, lot#7351400.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2023-00927; 0001825034-2023-00928.Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial total hip arthroplasty, the liner would not seat upon the acetabular shell.A second inlay was attempted and the same malfunction occurred.The acetabular shell was then removed and another shell and liner were implanted without complication.There was a surgical delay of 20-30 minutes to replace the shell and liner but no patient impact has been reported.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified there is scuffing on the liners.The device also has an indentation on the outer diameter.The liner was put in the shell to check the alignment of the scallops.It is unknown if the damage occurred during or prior to the assemble attempts.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: repeated failure to implant inlay, cup is removed, extensive rinsing of the cup bearing, reworking to size up, implant of 56 multi-hole cup in 10 deg anteversion and 45 deg inclination, implant of standard pe inlay.Root cause was unable to be determined.The complaint is confirmed based on review of returned products and medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information at time of this report.

Event Description

It was reported that a patient underwent a revision right total hip arthroplasty due to a osteosynthesis failure of a femoral neck fracture and erosion of the doroscranial acetabular rim.During the revision procedure, the liner would not seat upon the acetabular shell.A second inlay was attempted and the same malfunction occurred.The acetabular shell was then removed and a larger shell and liner were implanted without complication.There was a surgical delay of 20-30 minutes to replace the shell and liner but no patient impact has been reported.Due diligence is complete as multiple attempts have been made; all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: a1; a2; a3; a4; b4; b5; b7; d9; g3; h2; h3; h4; h10 the device has been received by zimmer biomet and is under evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: G7 10 DEG E1 LINER 36MM D
• 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: 16853100
• MDR Text Key: 314375815
• Report Number: 0001825034-2023-00929
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526754
• UDI-Public: (01)00880304526754(17)271012(10)7365532
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 010000895
• Device Catalogue Number: 010000895
• Device Lot Number: 7365532
• 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: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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.
• Patient Sex: Female
• Patient Weight: 116 KG