MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNI TIBIAL COMPONENT

Catalog Number 00584200301

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 05/27/2015

Event Type  Injury  

Event Description

It is reported that the patient was revised due to loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Visual inspection of the returned tibial plate identified that the anterior most medially edge of the rail fractured off.The fractured piece was returned for review.Scuff marks were identified on the proximal surface and gouging on the distal surface.Dimensions were found conforming to print specifications where measured.Sem analysis was performed on the returned tibial plate.Results revealed that the tibial plate fractured due to fatigue.Fatigue striations were observed with multiple crack initiation sites on the outer edge of the tibial plate.No obvious inclusions were identified on the sample fracture surface.Eds semi-quantitative elemental analysis revealed that the sample was consistent with tivanium alloy.Device history records were reviewed and no deviations or anomalies were found.This device is used for treatment.Two x-rays, one in the ml view and one in the ap view, dated were returned for review.It appears as though the fractured piece of the tibial plate edge can be observed.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.The package insert states that "fracture/damage of the prosthetic knee components or surrounding tissue" is an adverse effect.This is therefore a known inherent risk of the procedure.A product history search revealed no additional complaints against the related part and lot combination.The fracture was caused by fatigue, but a definitive root cause of the fatigue cannot be determined with the information provided.

• Brand Name: ZIMMER UNI TIBIAL COMPONENT
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4877605
• MDR Text Key: 18877069
• Report Number: 1822565-2015-01008
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 00584200301
• Device Lot Number: 60267437
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATALOG #00584201401, LOT #60268439.; UNI-KNEE HIGH-FLEX FEMORAL COMPONENT,; CATALOG #00584202308, LOT #60286212.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 98