MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL 2-PEG POROUS FXD BRG LT SIZE F; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unequal Limb Length (4534)

Event Date 01/30/2023

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.Additional associated products: 42502806201 femur trabecular metal cruciate retaining std porous lot# 63851544; 42512100714 articular surface medial congruent (mc) left 14 mm lot# 63040077.Additional event mdrs: implant loosening reported under mdr: 0001822565-2023-01269.

Event Description

It was reported during a revision surgery, while explanting the tibial component, a 1.5 cm piece of cortical and cancellous bone fractured.The tibial and polyethylene were exchanged.The femur component remained implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h10   no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified: tibia component found to be have some loosening to account for his pain.Upon removal of tibia component 'a large 1.5cm in diameter piece of cortical bone and cancellous bone came out with the medical peg.' this defect was repaired using tibial augments.The complaint is confirmed.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.

Event Description

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

• Brand Name: NATURAL TIBIA TRABECULAR METAL 2-PEG POROUS FXD BRG LT SIZE F
• 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: 17139666
• MDR Text Key: 317294255
• Report Number: 0001822565-2023-01548
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024510579
• UDI-Public: (01)00889024510579(17)280430(10)63905657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007501
• Device Lot Number: 63905657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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): Other
• Patient Sex: Male