MAUDE Adverse Event Report: ZIMMER INC SEGMENTAL DISTAL FEMORAL COMPONENT; KRO

Catalog Number 00585001202

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure to Anastomose (1028)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other device used: catalog #00585002012, segmental articular surface, lot #62720659 in returned photographs, the femoral component has visibly dislocated from the articular surface and come through the patient's incision.Surgical notes were not provided.It was reported that the patient had a collapse of the lateral condyle after the unknown total knee components were implanted, which threw the knee into severe valgus, but there was no implant failure.Due to the extensive loss of subchondral bone and the patient's ligamentous instability, the surgeon decided to implant the segmental system.Following the dislocation, it was reported that the original components remained implanted and an irrigation/debridement and reduction were performed after the dislocation and prior to closure of the knee.It was reported that the patient was being seen again for a second wash-out and an articular surface exchange on (b)(6) 2015, but this cannot be confirmed.Five x-rays were returned for review.One x-ray is for the unknown total knee and is likely the components implanted prior to the segmental system, described above; the components are severely malaligned.One x-ray was dated for (b)(6) 2015 and appears to be following the reduction of the segmental system.There is no indication that hyperextension occurred or the hinge post loosened and backed out.The package insert states that dislocation is an adverse effect.This is therefore a known inherent risk of the procedure.A definitive root cause cannot be determined with the information provided.

Event Description

It is reported that segmental components came through the incision.The surgical closure gave away.The surgeon used the same components and closed the patient once again.

• Brand Name: SEGMENTAL DISTAL FEMORAL COMPONENT
• Type of Device: KRO
• Manufacturer (Section D): ZIMMER INC; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5131092
• MDR Text Key: 27643321
• Report Number: 1822565-2015-02079
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 00585001202
• Device Lot Number: 62978970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 78