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

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: country: (b)(6).Literature: review of complications, functional outcome, and long-term survival following conversion of hip fusion to total hip arthroplasty.C.I.Ayekoloye, m.Abu qaoud, m.Radi, s.A.Leon, p.Kuzyk, o.Safir, a.E.Gross.The bone and joint journal.Doi:10.1302/0301-620x.103b7.Bjj-2020-2382.R1.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported one patient exhibited eccentric wear of the poly liner with superoacetabular osteolysis at 22 years after the primary operation.No additional information.Doi:10.1302/0301-620x.103b7.Bjj-2020-2382.R1.

• 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: 15026669
• MDR Text Key: 295958167
• Report Number: 0001822565-2022-02111
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNK CUP; UNK HEAD; UNK STEM
• Patient Outcome(s): Hospitalization; Required Intervention