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Model Number 11-3221-1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Damage to Ligament(s) (1952)
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Event Date 08/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of an audit of the dj orthopedics (b)(4), fda issued a finding on 13 december 2018 that "procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established." this report is being submitted as part of djo's efforts to address this finding.Device evaluated by mfr: one donjoy fullforce,acl,shrt cf,lt,xs (part number 11-3221-1, lot number 071217) was returned for evaluation.The product was evaluated.All the components are in good condition.The brace exhibits signs of excessive use., but there is no damage to the structure that would affect the patient.The brace works correctly.The device history record (dhr) was reviewed for the reported product.There was no information in the dhr that would indicate a problem that contributed to the reported complaint.Complaint data for similar products and issues going back 9 months has been reviewed.The trend indicates that reported customer complaints are within control.
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Event Description
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It was reported that the patient was walking down the hallway at school.It was very crowded in the hallways and kids where playing.Someone came behind her and kneed her from behind, causing her knee to buckle and her landing in awkward position while wearing her brace, re-tearing her anterior cruciate ligament (acl).The patient had to have revision reconstructive acl surgery on (b)(6) 2017.
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Search Alerts/Recalls
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