MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. SIZE JJ WITH CONSTRAINING RING CONSTRAINED LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Deformity/ Disfigurement (2360); Joint Dislocation (2374); Tissue Breakdown (2681)

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that approximately two years post-implantation the patient was revised due to a dislocation.A new liner was placed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D6: implant date: 2021.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 -03158.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.

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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

No further information is available at the time of this report.

• Brand Name: 28MM I.D. SIZE JJ WITH CONSTRAINING RING CONSTRAINED 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: 18149421
• MDR Text Key: 328292053
• Report Number: 0001822565-2023-03157
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024151833
• UDI-Public: (01)00889024151833(17)230131(10)63831140
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00875801128
• Device Lot Number: 63831140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 54 KG