(b)(4).Concomitant medical products: item# 010000589; comp rvrs 25mm bsplt ha+adptr; lot# 336680, item# 115397; comp rvs cntrl 6.5x35mm st/rst; lot# 335170, item# 180554; comp lk scr 3.5hex 4.75x35 st; lot# 657980, item# 115370; comp rvs tray co 44mm; lot# 108730.Reported event was confirmed by review of medical records which states that primary surgery was done due to degenerative joint disease of the right shoulder with rotator cuff tear (massive retracted tear that appeared to be unrepairable.A very large area of grade 3 & 4 chondromalacia about 4-5 cm over the superior dome of the humeral head and inferior aspect of the glenoid.A subdeltoid, subacromial, subconjoint tendon releases were performed.The biceps tendon was tenotimized.The humerus was osteotomized at 20 degrees of retroversion at the 45-degree inclination angle.The anterior-inferior capsule of the glenoid was completely removed.A 41 +3 head was impacted in the c-position.The shoulder was very stable through all ranges of motion.No complications noted.Revision surgery was done due to pain, loosening, implant fracture, metallosis, instability, and wear.X-rays revealed broken screws around the baseplate, the baseplate was loose, and scapular spine stress fracture.Multiple aspirations ruled out infection.Pseudocapsule was identified and removed.Cultures and gram stain sent (no report provided).No purulence.There was some metallosis from the patients instability.All three screws were broken.Significant anterior-superior wear to the glenoid.All products were removed easily.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event: 0001825034-2019-02628, 0001825034-2019-04078, 0001825034-2019-04080, 0001825034-2019-02629.
|
It was reported patient underwent a revision procedure approximately one post-implantation due to pain, loosening, implant fracture, metallosis, instability, and wear.No additional patient consequences were reported.
|