MAUDE Adverse Event Report: ZIMMER INC NEXGEN CR-FLEX GSF POROUS FEMORAL COMPONENT; MBH

Catalog Number 00575201702

Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).No devices or photos were received; therefore the condition of the components is unknown.Review of the device history records for the femoral component found no deviations and anomalies.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.However, the complaint may be revised upon return of product or further information.

Event Description

It is reported that the patient was revised due to pain and loosening of femoral component.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.The device history records for the femoral were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.A product history search identified no other complaint for the part and lot combination of the femoral component.The patient underwent a total knee arthroplasty on the contra-lateral (left) side in 2011, with no post-operative complications.Both the primary and revision operative notes were translated from german using a free available translation software.Review of the translated primary operative notes suggests that the components were implanted with the correct fit and orientation as per the surgical technique, although the femoral component was implanted after the tibial component was cemented in position and the articular surface implemented on the tibial component.These notes also state that: "the postoperative radiograph shows a normal implant location with proper tracking of the patella in 0/0/120 degrees." the translated revision pre-operative notes state that: "radiologically there is a radiolucency at the bone-implant interface in the region of the femursteiles so that clinically there is suspicion of a femoral loosening and instability present in the area of the posterior cruciate ligament." per the nexgen cr-flex and lps-flex gender solutions female (gsf), knee femoral components package insert, loosening of the prosthetic knee components and pain are known adverse effects of this procedure.

• Brand Name: NEXGEN CR-FLEX GSF POROUS FEMORAL COMPONENT
• Type of Device: MBH
• 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: 5101369
• MDR Text Key: 26682529
• Report Number: 1822565-2015-01947
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 00575201702
• Device Lot Number: 62421527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2013
• 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): Other; Required Intervention
• Patient Age: 53 YR