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U.S. Department of Health and Human Services

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

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ZIMMER INC NEXGEN CR-FLEX GSF POROUS FEMORAL COMPONENT MBH Back to Search Results
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.
 
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Brand NameNEXGEN CR-FLEX GSF POROUS FEMORAL COMPONENT
Type of DeviceMBH
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 Key5101369
MDR Text Key26682529
Report Number1822565-2015-01947
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00575201702
Device Lot Number62421527
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2015 Patient Sequence Number: 1
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