SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202901 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); Osteolysis (2377)
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Event Date 07/01/2012 |
Event Type
Injury
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Event Description
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It was reported that, after an arthroscopic rotator cuff repair, the patient developed osteolysis around the footprint ultra suture anchor.It is unknown if the event required additional treatment.The patient's outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H11: correction on the facility information.
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Manufacturer Narrative
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H10, h6: evaluation is not possible, as the device will not be returned.The lot number has not been provided making an examination of the manufacturing records prohibitive.A review of the complaint records was performed for this device, which confirmed additional allegations have been reported within the scope of the reported study.The investigation was limited to the information provided.This investigation could not draw any conclusions about the reported event with the limited clinical details provided.If additional details become available in the future, the investigation will be reopened.The data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.
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Search Alerts/Recalls
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