ZIMMER BIOMET, INC. POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Hematoma (1884); Joint Dislocation (2374)
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Event Date 04/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: 00585002014 64510506 articular surface with segmental hinge post; 00599003420 63553256 femoral augment; 00598801112 63542117 stem extension straight; 00598802017 63082997 stem extension offset.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03263.
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Event Description
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It was reported the patient underwent an initial right total knee arthroplasty.Subsequently, the patient was revised approximately 2 years post implantation through a 2 stage revision to a rotating hinge knee.Approximately 6 days post revision, it was reported the patient¿s leg failed and he slipped off the bed when he got up in his room on the ward.The patient hypereflexed his right knee while sutures were still in situ from the previous revision.He had an open reduction of a joint dislocation with lavage and reconstruction of the capsular ligament of the knee joint.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records received.Review of the available records identified the following: patient fell, legs failed, slipped off the bed when he got up and hyperflected the right knee joint while sutures were still in.Resulted in insufficiency of the ventral capsule suture, subcutaneous tissue suture and the skin suture with dislocation of the right knee joint.Remaining sutures material removed, hematoma evacuated, lavage performed.Poly was placed in diluted betadine solution for about one hour and rinsed.No further dislocation, loosening or mechanical complications noted upon completion which checked movement sequence correct.The device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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