Model Number N/A |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Type
Injury
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-05439 / 05440).
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Event Description
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Patient reported right elbow revision approximately one year post-implantation due to pain and loss of range of motion.Patient reported the prosthesis implanted was too long and too big and that synovial fluid was removed during the revision.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.
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Manufacturer Narrative
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Provided x-rays were evaluated and the reported event was not confirmed.Appropriate size selection is done intraoperatively by using the native head size as a comparative measure to choose the arthroplasty size.Secondary signs of an oversized hardware component include widening of the ulnohumeral space.However the provided views to not allow for assessment of this joint space.The provided image suggests there may be lucency in the distal humerus (condylar region), but this may be artifactual in nature.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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