MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FINN MOD TIBIAL BEARING STD 22; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Joint Swelling (2356)

Event Date 08/07/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: p/n 150479 oss reinforced yoke l/n 412810, p/n 153803 finn segmental rt femoral l/n 129420, p/n 153851 finn tibial bushing l/n 126190, p/n 153852 finn femoral bushing set of 2 l/n 234670, p/n 153872 finn axle l/n 241740, p/n 153992 finn mod tibial bearing std 22 l/n 992340, p/n 150410 oss tibial poly bearing 12mm l/n 249130, p/n 150443 oss mod prox tib 9cm l/n 811890.P/n 150446 oss cmntd prox tib stem 13x150 l/n 023950.P/n 153841 finn lg locking screw l/n 139210.P/n 150479 oss reinforced yoke l/n 412810.P/n 153803 finn segmental rt femoral l/n 129420.P/n 153851 finn tibial bushing l/n 126190, p/n 153852 finn femoral bushing set of 2 l/n 234670, p/n 153872 finn axle l/n 241740.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 a right knee infection.Warmth, swelling, pain, and discomfort were reported.It should be noted, the patient has been on chronic antibiotic suppression since the age of 13.Upon stopping the use of the antibiotics, the patient developed coag-negative staphylococcus infection of her right knee.An irrigation and debridement as well as a one-stage exchange procedure was performed.Upon entering the joint space, it was found to be filled with purulent material, which was drained.The joint was inspected and the polyethylene spacer of 12 mm thickness was found to be fractured anteriorly just beneath the medial femoral condyle.The axle, bushings and yoke were subsequently removed along with the bearing surface.No further information is available at this time.

• Brand Name: FINN MOD TIBIAL BEARING STD 22
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6882663
• MDR Text Key: 87179544
• Report Number: 0001825034-2017-07087
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK945028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2005
• Device Model Number: N/A
• Device Catalogue Number: 153992
• Device Lot Number: 992340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2000
• 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): Hospitalization; Required Intervention
• Patient Age: 29 YR