It was reported that the patient had an initial left shoulder arthroscopy.The patient complains of pain, stiffness, inflammation, decreased rom, bursitis, and an allergic reaction to the bovine-derived material of the implant.No additional patient consequences were reported.
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h4, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.The reported patient symptoms are confirmed via provided medical records, however, allergy is not comfirmed.Review of the available records identified the following: dr knudsen note left shoulder pain, stiffness, capsulitis, and possible inflammatory reaction to bio inductive collagen scaffold s/p left shoulder arthroscopic debridement, subacromial decompression with partial acromioplasty, and partial rotator cuff repair with placement of an embody tapestry collagen scaffold implant.Postop arthroscopy: sling for 4-5 days, pt starting at 1 week postop with limited progress at 3 months, severe pain since with decreased rom and hard stop, intermittent spasms, increased warmth mri report impression: postsurgical changes about the superior rotator cuff, supraspinatus tendinosis, mild glenohumeral degenerative joint disease, suspect tearing of superior labrum, nonspecific inferior glenohumeral ligament edema, narrowed acromiohumeral interval with mild subacromial spurring.Letter from siri & glimstad.Pdf additional shoulder conditions including inflammation, bursitis, and adhesive capsulitis.Systemic inflammation and rheumatic symptoms quickly returned postop due to allergic reaction to bovine derived material of implant.Additional shoulder conditions including inflammation, bursitis, and adhesive capsulitis.Systemic inflammation and rheumatic symptoms quickly returned postop due to allergic reaction to bovine derived material of implant.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.
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