MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)

Patient Problem Osteolysis (2377)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: italy.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial hip procedure on an unknown date where competitor product was implanted.Subsequently, approximately 11 (eleven) years later, the patient undergoes a revision of competitor product where a zimmer biomet cup, liner and head are implanted.During the post operative period in the hospital, the cup and liner disassociates.The patient undergoes a second revision approximately 1 (one) week later to fix the liner and cup.During the revision, the surgeon is unable to mate the liner with the cup.The liner and cup are explanted leading to major bone loss for the patient.Attempts have been made and no further information has been provided.

• Brand Name: UNK 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: 19173415
• MDR Text Key: 340935059
• Report Number: 0001822565-2024-01394
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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: UNKNOWN STEM.; UNKNOWN ZIMMER BIOMET HEAD.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male