MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROLONG ARTICULAR SURFACE LPS/LPS-FLEX EF 10 MM H; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device 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 the patient was revised due to an implant fracture.The poly was exchanged successfully.The articular surface post was fractured off the poly.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised for instability.During the revision it was found the articular surface post was fractured off the poly.Poly was exchanged without complications.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  visual examination of the provided pictures identified the unit as fractured in two places.Part and lot identification are necessary for review of device history records, lot number was not provided.Therefore, a dhr review was not completed.Insufficient information provided to perform a compatibility check.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right knee arthroplasty components are anatomically aligned, no osseous fracture or implant loosening, bone quality osteopenic.The complaint is confirmed via provided pictures.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: PROLONG ARTICULAR SURFACE LPS/LPS-FLEX EF 10 MM H
• Type of Device: PROSTHESIS, KNEE
• 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: 18326014
• MDR Text Key: 330494255
• Report Number: 0001822565-2023-03585
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 00596204010
• Device Lot Number: 65356565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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