MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE II ELEVATED RIM LINER; PROSTHESIS, HIP

Catalog Number 00875201036

Device Problems Fracture (1260); Difficult to Insert (1316); Material Twisted/Bent (2981)

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

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: cat #: 00877503601 / biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 / cat #: 31445830.G2: brazil.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.

Event Description

It was reported that during the procedure while trying to reduce the head into the acetabulum, the rim of the poly liner bent inward and made it difficult for the head to fully assemble.Another liner and head were used to complete the procedure.There was no harm or health impact to the patient.It was reported that no further information is available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the liner rim is deformed/bent and broken on one side.The device is covered in bio-debris.No further evaluations can be made from the provided pictures.The complaint was confirmed based on the provided pictures.Dhr was reviewed and no discrepancies related to the reported event were found.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: 36MM I.D. SIZE II ELEVATED RIM LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18066376
• MDR Text Key: 327298346
• Report Number: 0001822565-2023-03068
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024149724
• UDI-Public: (01)00889024149724(17)271229(10)65740009
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K200823
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00875201036
• Device Lot Number: 65740009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2022
• 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: Male