ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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Model Number UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Hematoma (1884); Failure of Implant (1924); Tissue Breakdown (2681)
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Event Date 11/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported via the surgical outcome system that a patient was having complications possibly related to a prior implanted arthrex product.Complications mentioned were hematoma.Additional information obtained 12/3/2019: the surgeon's representative has confirmed that a patient had an initial prior rotator cuff repair and required a second left reverse shoulder arthroplasty on (b)(6) 2019.The operative report from (b)(6) 2019 noted that three metal corkscrew anchors had been explanted prior to proceeding with the procedure.During the procedure the following arthrex products were implanted: ar-9564-2442-lat (modular glenosphere), ar-9501-07s (humeral stem) and ar-9502f-42lcpc (suture cup).On (b)(6) 2019 the patient was admitted to the hospital urgently after his large hematoma began to have wound breakdown and he had anemia with symptomatic atrial fibrillation with rvr.Surgeon admitted the patient for surgical exploration with evacuation of hematoma, debridement, exploration of tendon transfer site and administration of local antibiotics.Operative report noted there was no evidence of infection and the subscapularis repair and the tendon transfer repair were intact.The prosthesis was also located and appeared in good position.The prosthesis implanted on (b)(6) 2019 were not explanted during the (b)(6) 2019 procedure.Additional information obtained 12/6/19: the surgeon's office has confirmed that the patient's original rotator cuff procedure was approximately 15 years prior and was performed by a different surgeon in a completely different area of the state.There is no additional information known regarding this original procedure or any implants that may have been used at that time.
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