SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 72203379 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Erythema (1840); Swelling (2091); Patient Problem/Medical Problem (2688)
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Event Date 12/17/2018 |
Event Type
Injury
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Event Description
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It was reported that 6-7 weeks after shoulder surgery performed on (b)(6) 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patient's shoulder.Subsequently on (b)(6) 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection.It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection.Current patient status is unknown, however, no further complications have been reported.
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Manufacturer Narrative
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One 72203379 healicoil pk 5.5mm-2 ub blue-cobraid device was reported on.The complaint was received from rotation medical and shared with smith and nephew.The complaint indicated that a massive tear was repaired with multiple suture anchors.5 complaints were opened to record the revision and the smith and devices used.A subsequent ¿implant rejection¿ was noted with redness, swelling and pain.Due to product unavailability, the complaint could not be visually evaluated.Evaluation results were based upon information relayed.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include.
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Event Description
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It was reported that 6-7 weeks after shoulder surgery performed on 25 oct 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patients shoulder.Subsequently on 17 dec 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection.It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection.Current patient status is a full passive range of motion but limited active range of motion, allowed to gradually resume activity as tolerated, with no trauma during her recovery.
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Search Alerts/Recalls
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