BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK ABSORBABLE ANCHOR IMPLANT

    MDR report key: 3041016 · Received April 8, 2013

    Report

    Report Number
    1221934-2013-00096
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    October 9, 2003
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K002639
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE NO OTHER INFORMATION IS AVAILABLE. IT IS NOT KNOWN WHEN OR IF THE DEVICE WILL BE RETURNED TO DEPUY MITEK FOR EVALUATION AND ROOT CAUSE ANALYSIS. A PRODUCT CODE OR BATCH NUMBER HAS NOT BEEN PROVIDED WHICH PRECLUDES A BATCH REVIEW FROM BEING CONDUCTED. AT THIS POINT IN TIME NO CORRECTIVE OR FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    TO DATE IT IS NOT KNOWN WHEN OR IF THE DEVICE WILL BE RETURNED TO DEPUY MITEK FOR EVALUATION AND ROOT CAUSE ANALYSIS. A PRODUCT CODE OR BATCH NUMBER HAVE NOT BEEN PROVIDED WHICH PRECLUDES A BATCH REVIEW FROM BEING CONDUCTED. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE ADDED TO THE FILE AND A FOLLOW-UP MEDWATCH REPORT WILL BE FILED ACCORDINGLY. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT REPORTEDLY SUFFERED PAIN AND DISCOMFORT AFTER HAVING A DEPUY MITEK PANALOK 3.5 MM ANCHOR WITH SUTURE IMPLANTED IN THE RIGHT SHOULDER. THE PATIENT REQUIRED AN ADDITIONAL SURGERY. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT FELL FROM A DEER STAND LADDER IN 2002 AND EXPERIENCED RIGHT SHOULDER PAIN ONLY AFTER A FEW MONTHS. A CT-SCAN REVEALED A LARGE CYST IN THE POSTERIOR/INFERIOR BODY OF THE GLENOID AND A PARALABRAL CYST. THE LARGE CYST WAS ASPIRATED AND PATHOLOGY WAS BENIGN. THE PAIN PERSISTED AND AN ARTHROSCOPY WAS PERFORMED WHICH FOUND A SLAP LABRUM TEAR AND A SUBACROMIAL SPACE SOCKED WITH BURSITIS TISSUE. IT WAS DEBRIDED WITH A SHAVER AND THE CORACOACROMIAL LIGAMENT WAS RELEASED. A PAIN PUMP WAS PLACED AT THE END OF THE PROCEDURE. HE DID WELL FOR A FEW WEEKS AND THEN EXPERIENCED PAIN RADIATING DOWN THE POSTERIOR ASPECT OF HIS ARM EXTENDING TO HIS FOREARM AND TOWARDS HIS HAND. HE ALSO HAD PARASPINAL PAIN ON THE SAME SIDE. THREE MONTHS AFTER THE ARTHROSCOPY, HE UNDERWENT AN ARTHROSCOPIC SLAP III REPAIR AND A RESECTION OF THE DISTAL CLAVICLE. THE SURGEON ATTEMPTED TO USE A KNOTLESS ANCHOR BUT THEN DECIDED TO USE THREE PANALOK ANCHORS. A PAIN PUMP WAS PLACED AT THE END OF THE PROCEDURE. AFTER THE OPERATION, THE PAIN IMPROVED AND HE HAD GOOD SHOULDER RANGE OF MOTION. SUBSEQUENTLY, THE PATIENT UNDERWENT MULTIPLE PROCEDURES OVER THE NEXT 9 YEARS (WHICH APPEAR TO BE UNRELATED TO THE LABRAL REPAIR WITH PANALOK ANCHORS), AS THE PAIN RETURNED GENERALLY A FEW WEEKS AFTER EACH INTERVENTION: (1) OPEN SUBACROMIAL DECOMPRESSION, (2) CT-GUIDED ASPIRATION OF GLENOID CYST, (3) FLUOROSCOPY-GUIDED SUPRASCAPULAR NERVE BLOCK, (4) CERVICAL INTERLAMINAR STEROID INJECTION, (5) ARTHROSCOPIC DEBRIDEMENT OF THE SUBACROMIAL SPACE, (6) THREE L4-L5 EPIDURAL STEROID INJECTIONS, (7) MULTIPLE INJECTIONS OF STEROIDS IN SUBACROMIAL SPACE, (8) ACROMIOPLASTY, EXCISION OF DISTAL CLAVICLE, BICEPS TENODESIS, SUPRASCAPULAR NERVE RELEASE, STELLATE GANGLION BLOCK (9) AXILLARY NERVE RELEASE, QUADRILATERAL SPACE EXPLORATION AND RELEASE AND TRIGGER POINT DENERVATION, EVENTUALLY LEADING TO (10) SHOULDER TOTAL ARTHROPLASTY. AFTER THE SHOULDER REPLACEMENT, HE DID WELL FOR A FEW MONTHS BUT HAD A FALL AND REINJURED HIS SHOULDER. HE HAD A SCOPE AND THEN A SUBSCAPULARIS REPAIR. THREE YEARS AFTER THE SHOULDER REPLACEMENT, HE HAD A SHOULDER INFECTION FOR WHICH HE UNDERWENT ARTHROSCOPIC DEBRIDEMENT AND IV ANTIBIOTIC TREATMENT. DURING THESE YEARS HE HAD MULTIPLE SPINE X-RAYS AND MRIS SHOWING MILD DEGENERATIVE DISEASE AND MULTIPLE EMG/NERVE CONDUCTION STUDIES OF THE RIGHT UPPER EXTREMITY WITH NORMAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143738 MITEK ABSORBABLE ANCHOR IMPLANT ANCHOR IMPLANTS MAI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR