ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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Model Number UNIVERS REVERS HUMERAL STEM, 5MM |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 01/16/2020 |
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 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 that a revision reverse total shoulder took place on (b)(6) 2020.The rep reported the revision procedure was due to a high suspicion of an infection, and the baseplate loosening.Prior to the revision procedure the patient was experiencing pain and swelling around the surgical site.X-rays were taken during a follow-up visit and revealed the loosened baseplate.Cultures were taken during the revision procedure and sent for testing.At this time an infection has not been confirmed.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The rep reported at this time the date of the primary surgery, and full list of arthrex product implanted during the primary procedure is currently unknown.Additional information has been requested.The following arthrex parts were explanted during the revision procedure: ar-9503-3633-3 / lot: 18.00158 / qty.: 1, ar-9501-05p / lot: unknown / qty.: 1, ar-9555-06 / lot: 18.01505 / qty.: 1, ar-9502f-36cpc / lot: 18.00745 / qty.: 1, ar-9564-2433-lat / lot: 17.04762 / qty.: 1, ar-9563-16 / lot: 18.00182 / qty.: 1.An arthrex baseplate and screw were also removed.However, the part and lot numbers are currently unknown.
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