BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSS KEELED GLENOID S

    MDR report key: 4644939 · Received March 24, 2015

    Report

    Report Number
    1651501-2015-00007
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 9, 2015
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K130050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE FAILURE ANALYSIS CANNOT BE CONDUCTED AT THIS TIME. THE COMPLAINT CANNOT BE CONFIRMED AT THIS TIME. FURTHER ANALYSIS MAY BE CONDUCTED AT A LATER DATE IF MORE INFORMATION BECOMES AVAILABLE OR THE DEVICE IS RETURNED FOR EVALUATION A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 11-1150 OF P/N GLN-0920-030-01K (KEELED GLENOID SIZE SMALL) REVEALED THAT IT SATISFIED ALL APPLICABLE MANUFACTURING SPECIFICATIONS. NO NON-CONFORMANCES WERE PRESENT AND NO ISSUES WERE IDENTIFIED THAT WOULD CAUSE OR CONTRIBUTE TO THE EVENT. DATE OF MANUFACTURE IS 03/26/11. A REVIEW OF COMPLAINT RECORDS FOUND NO OTHER COMPLAINTS DURING THE PREVIOUS (B)(6) MONTHS FOR ANY SIMILAR TYPES OF EVENTS INVOLVING TSS IMPLANTS. BASED ON THESE DATA, THERE IS AN APPROXIMATE OCCURRENCE RATE OF (B)(4). CONCLUSION: A REVIEW OF MANUFACTURING RECORDS FOR THE COMPLAINT RELATED LOT FOUND THAT ALL APPLICABLE MATERIAL, PROCESS AND FINISHED COMPONENT SPECIFICATIONS WERE SATISFIED. MANUFACTURING AND COMPONENT DEFECTS ARE ELIMINATED AS POSSIBLE ROOT CAUSES. BASED ON THE LACK OF SIMILAR COMPLAINTS OF THIS TYPE, THE MOST LIKELY CAUSE IS THE USE OF EXCESSIVE IMPACTION FORCE ON THE IMPLANT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. BASED ON REPORTED INFORMATION, INTEGRA HAS INITIATED AN INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FACE OF THE KEELED GLENOID SEPARATED FROM THE KEELED STEM. THE BONE WAS PREPARED PER THE TECHNIQUE. THERE WAS NOTHING ABNORMAL ABOUT THE BONE ITSELF. CEMENT WAS PRESSURIZED 3 TIMES. THE SURGEON IMPLANTED THE KEELED GLENOID AND WAITED FOR THE CEMENT TO DRY. ONCE THE CEMENT WAS DRY HE PUSHED ON THE GLENOID AND IT ROCKED SUPERIOR AND INFERIORLY. IT DID NOT ROCK ANTERIOR/POSTERIOR. ASSUMING IT WAS LOOSE HE PULLED ON THE IMPLANT BUT IT WOULD NOT COME OUT OF THE BONE. THE KEELED STEM WAS WELL FIXED. USING AN OSTEOTOME HE GENTLY TRIED TO NUDGE THE IMPLANT OUT OF THE BONE. THE FACE OF THE GLENOID IMPLANT SEPARATED FROM THE KEELED STEM WITHOUT MUCH FORCE. WITH THE KEEL STUCK IN THE BONE HE HAD TO CONVERT THE SHOULDER FROM AN ANATOMIC TO A REVERSE. THE SURGEON MENTIONED THAT THE PATIENT HAD BEEN CONSENTED (INFORMED) THAT THE SURGERY COULD RESULT IN AN ANATOMIC OR REVERSE SHOULDER PROCEDURE. THE SURGEON IS LOOKING FOR AN EXPLANATION AS TO WHY THIS HAPPENED. HE HAS NOT SEEN THIS HAPPEN BEFORE. ADDITIONAL INFORMATION REQUESTED ON BEHALF OF PRODUCT INVESTIGATORS BY REPORTER 12FEB15: I SUBMITTED THE INFORMATION YOU GAVE ME IN YOUR SYSTEM A SA COMPLAINT SO THAT WE COULD OPEN UP A PROPER INVESTIGATION. I ALSO DISCUSSED THE INCIDENT WITH THE ENGINEERING TEAM AND THERE ARE A FEW CLARIFYING QUESTIONS: WHEN USING THE OSTEOTOME, WAS THE TIP PLACED ON THE IMPLANT OR BONE? DO YOU THINK IT CAME IN CONTACT WITH THE KEEL? WAS THE OSTEOTOME PLACED, SUPERIORLY, ANTERIORLY OR IN WHICH DIRECTION? WHAT WAS USED TO IMPACT THE GLENOID AND HOLD CEMENT WHILE CURING? COULD YOU ESTIMATE HOW MUCH ROCKING THERE WAS? FOR EXAMPLE - DID IT LIFT OFF THE BONE 2 MM? DO YOU MIND IF THE INVESTIGATOR FORM THE COMPLAINT DEPARTMENTS CONTACTS YOU DIRECTLY IF THERE ARE ANY OTHER QUESTIONS? REPLY RECEIVED 12FEB15: WHEN USING THE OSTEOTOME, THE TIP OF IT WAS PLACED BETWEEN THE IMPLANT AND BONE. I DO NOT BELIEVE IT CAME IN CONTACT WITH THE KEEL. I WAS TRYING TO KEEP THE IMPLANT INTACT. THE OSTEOTOME WAS PRIMARILY USED ANTERIORLY. I USED THE DEFINED IMPACTOR DEVICE AND HELD IT IN PLACE WITH MY THUMB WHILE THE CEMENT CURED. I WOULD GUESS THAT ABOUT 1-2 MM OF ROCKING WAS SEEN. IT WASN'T MUCH, BUT IT WAS ENOUGH TO SEE A GAP BETWEEN THE IMPLANT AND BONE SUPERIORLY. THE ROCK OCCURRED ONLY WHEN I WOULD PUSH ON THE BOTTOM OF THE IMPLANT. I CAN BE CONTACTED ON MY CELL ANYTIME. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON VIA PHONE CALL 25FEB2015: THERE WAS NO PATIENT INJURY. THE PATIENT WAS AWARE SHE MIGHT GET A REVERSE SHOULDER PROCEDURE. THE REASON FOR CHANGING TO A REVERS SHOULDER PROCEDURE WAS DIFFERENT THAN WHAT HE (THE SURGEON) EXPECTED. HE SUSPECTS THIS IS A UNIQUE EVENT. IT WAS DIFFICULT FOR HIM TO CONVERT TO THE NEXT PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196335 TSS KEELED GLENOID S TITAN TOTAL SHOULDER KWS ASCENSION ORTHOPEDICS 11-150

    Patients

    Seq Age Sex Outcome Treatment
    1