BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3110959 · Received May 9, 2013

    Report

    Report Number
    1822565-2013-00774
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 19, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FIT AND ORIENTATION COULD NOT BE EVALUATED WITHOUT X-RAYS OR SURGICAL NOTES. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND POSSIBLE RECENT TRAUMA ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE CONDYLAR PADS OF THE ARTICULAR SURFACE WERE DISCOLORED AND THE SPINE HAD BEEN FRACTURED OFF OF THE DEVICE AS RECEIVED. THE MANUFACTURING DOCUMENTATION WAS REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT INFORMATION. ((B)(6) 2009). CONCOMITANT MEDICAL PRODUCTS - LOT # CORRECTION FOR ZIMMER NEXGEN FLUTED STEMMED TIBIAL COMPONENT, SIZE 2 CATALOG #00-5996-028-02, LOT #61138419. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - ZIMMER NEXGEN LPS-FLEX GSF OPTION FEMORAL COMPONENT, SIZE D CATALOG# 00-5764-014-52, LOT#61095981. ZIMMER NEXGEN FLUTED STEMMED TIBIAL COMPONENT, SIZE 2 CATALOG# 00-5996-028-02, LOT# 61198419. ZIMMER NEXGEN LPS-FLEX ARTICULAR SURFACE CD 1-2, SIZE 10MM. CATALOG#00-5962-022-10, LOT# 60695745. ZIMMER NEXGEN ALL POLY PATELLA, 29MM * 8MM CATALOG# 00-5972-065-29, LOT# 61140474. PALACOS R RADIOPAQUE BONE CEMENT CATALOG# 00-1112-140-01, LOT# 67164134. COMPLAINT SAMPLE WAS PREVIOUSLY RECEIVED, AND REPORTED EVENT WAS CONFIRMED AT THAT TIME. NEW INFORMATION RECEIVED INCLUDED SURGICAL NOTES FOR PRIMARY AND REVISION SURGERY, WHICH WERE PROVIDED FOR REVIEW. THE PRIMARY SURGERY NOTES INDICATE ADVANCED OSTEOARTHRITIS IN RIGHT KNEE; DICTATION TAKEN APPEARS TO INDICATE SURGICAL TECHNIQUE WAS FOLLOWED BY SURGEON. HOWEVER, REVISION OPERATIVE NOTES POINT TO PROGRESSIVE LAXITY AND HYPEREXTENSION, AS WELL AS SYSTEMATIC CONNECTIVE TISSUE DISORDER WITH LIGAMENTOUS LAXITY. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND POSSIBLE RECENT TRAUMA ARE UNKNOWN. REVIEW OF THE COMPATIBILITY MATRIX IDENTIFIED THAT THE IMPLANTS USED TOGETHER ARE COMPATIBLE FOR USE (FEMORAL WITH ARTICULAR SURFACE AND PATELLA; TIBIA WITH ARTICULAR SURFACE). REVIEW OF THE COMPLAINT HISTORY FOUND NO OTHER REPORTS OF THIS NATURE FOR THE REPORTED PART/LOT COMBINATION. IN THE ASSOCIATED PACKAGE INSERT, FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS AND JOINT INSTABILITY ARE LISTED AS A POSSIBLE ADVERSE EFFECT. MOREOVER, RISK ASSESSMENT IDENTIFIED PATIENT CONDITION (PROGRESSIVE LAXITY AND HYPEREXTENSION) CONTRIBUTION ON ARTICULAR SURFACE FRACTURE AND REVISION SURGERY. A DEFINITIVE ROOT CAUSE CAN BE DETERMINED AS THE PATIENT'S JOINT LAXITY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DURING THE REVISION SURGERY, IT WAS FOUND THAT THE POST HAD FRACTURED OFF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204775 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 60695745

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention