BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMICAP PATELLO-FEMORAL WAVE RESURFACING PROSTHESIS

    MDR report key: 12677976 · Received October 21, 2021

    Report

    Report Number
    3004154314-2021-00004
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Report Date
    September 21, 2021
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KRR
    PMA / PMN Number
    K071413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, ARTHROSURFACE PERSONNEL REACHED OUT TO THE PATIENT TO OBTAIN ADDITIONAL INFORMATION REGARDING HER ISSUES/ CONCERNS. HOWEVER, NO NEW INFORMATION WAS PROVIDED OTHER THAN WHICH SHE HAD ALREADY PROVIDED TO ARTHROSURFACE. THE EXACT REASON FOR THE ISSUES/ CONCERNS REPORTED BY THE PATIENT ARE UNKNOWN. AS PART OF THE INVESTIGATION, THE DEVICE HISTORY RECORDS (DHRS) OF THE LOTS THAT PATIENT RECEIVED (IN LEFT KNEE) WERE REVIEWED. ALL UNITS WERE BUILT TO SPECIFICATION. THERE WERE NO REJECTS OR NON-CONFORMING UNITS FROM EITHER OF THE LOTS IN QUESTION. NO OTHER COMPLAINTS CONCERNING A PATIENT-IMPACT, OR A QUALITY ISSUE WERE REPORTED FOR THE LOTS IN QUESTION TO DATE. THE FOLLOWING CONCLUSIONS WERE MADE BY (B)(6) AND QA/ RA TEAMS FOLLOWING A REVIEW OF THE INFORMATION PROVIDED BY THE PATIENT. THE RADIOGRAPHS TAKEN IMMEDIATELY AFTER SURGERY (T=0) WERE NOT PROVIDED WHICH COULD BE HELPFUL TO SEE THE TAPER INTERLOCK BETWEEN THE FEMORAL ARTICULAR AND FIXATION COMPONENTS. THE IMPLANT FRACTURE/ BREAKAGE REPORTED BY THE PATIENT AND HER PRIMARY PHYSICIAN COULD NOT BE CONFIRMED FROM THE RADIOGRAPHS AND THE PICTURES PROVIDED TO ARTHROSURFACE. SINCE THE IMPLANTS WERE NOT RETURNED TO ARTHROSURFACE IT IS NOT POSSIBLE TO CONFIRM BREAKAGE OF THE IMPLANT AS REPORTED. THE IMPLANT IS A TWO-PIECE CONSTRUCTION, WITH A SEPARATE FIXATION COMPONENT AND ARTICULAR IMPLANT CONNECTED BY A SECURE TAPER. THE RADIOGRAPH SHOWS THE COMPONENTS ARE NO LONGER ENGAGED BUT DOES NOT APPEAR ON IMAGE TO BE FRACTURED OR BROKEN IN ANY WAY. REVIEW OF IMAGING: THERE ARE NO INDICATIONS OF DISCONTINUITY OR FRACTURE WITHIN ANY OF THE COMPONENTS. NO LOOSE OR DISASSOCIATED PARTICLES COULD BE SEEN WITHIN OR AROUND THE COMPONENTS. REVISION CASE NOTES: THE REVISION SURGEON CONFIRMED THAT THE FEMORAL ARTICULAR COMPONENT WAS DISENGAGED FROM THE TAPER POST COMPONENT WHICH APPEARED TO BE WELL FIXATED. AS SUCH, THE PATELLA COMPONENT HAD A GOOD FIXATION. THERE WERE NO REMARKS OF IMPLANT BREAKAGE / FRACTURE AS REPORTED BY THE PATIENT OR HER PRIMARY PHYSICIAN. THE PF WAVE IMPLANT WAS TESTED TO WITHSTAND NORMAL PHYSIOLOGICAL AND OVERLOAD EVENTS. TEST DATA ON FILE. REVIEW OF IFU: LOOSENING OR LOSS OF FIXATION OF THE IMPLANT IS CONSIDERED AS ONE OF THE RISKS ASSOCIATED WITH THE PF WAVE ARTHROPLASTY SYSTEM. BASED ON THE ABOVE CONCLUSIONS, THERE IS NOT ENOUGH EVIDENCE TO ASCERTAIN THAT THE ARTHROSURFACE DEVICE MECHANICALLY FAILED. THE COMPLAINT FILE WILL BE CLOSED WITH NO ADDITIONAL ACTIONS OR FOLLOW-UP ACTIVITIES. ANY ADDITIONAL INFORMATION RECEIVED WILL BE ADDED TO THE COMPLAINT FILE. BELOW ARE THE IMPLANT COMPONENTS THAT THE PATIENT RECEIVED: ARTICULAR COMPONENT, PN: PX02-1005-W, LOT NUMBER: 75JF2022, MFG. DATE: 11/07/2016, EXP. DATE: 11/07/2023. TAPER POST, PN: PX11-0218-W, LOT NUMBER: 75DG0424, MFG. DATE: 05/01/2017, EXP. DATE: 05/01/2022.

    Description of Event or Problem · 0

    PATIENT RECEIVED ARTHROSURFACE PF WAVE IMPLANT IN HER LEFT KNEE ON (B)(6) 2017. SINCE (B)(6) 2021, SHE STARTED EXPERIENCING UNUSUAL PAIN IN HER LEFT KNEE. DURING A VISIT TO THE PRIMARY PHYSICIAN IN (B)(6) 2021, SHE WAS TOLD HER IMPLANT WAS FRACTURED WITH A DEFECT AND DISPLACEMENT AT THE JUNCTION OF THE CANNULATED SCREW AND THE PROSTHESIS OF THE ARTICULAR SURFACE. THE PRIMARY PHYSICIAN RECOMMENDED REMOVAL OF THE IMPLANT AND REVISE TO A TKA. ON (B)(6) 2021, PATIENT'S LEFT KNEE WAS REVISED TO TKA AND THE PF WAVE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576274 HEMICAP PATELLO-FEMORAL WAVE RESURFACING PROSTHESIS KNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS KRR ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female