ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST SCREW SIZE F 12 MM HEIGHT; PROSTHESIS, KNEE
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Catalog Number 00588006012 |
Device Problems
Device Dislodged or Dislocated (2923); Migration (4003)
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Patient Problems
Failure of Implant (1924); Joint Dislocation (2374)
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Event Date 01/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: femoral component option for cemented use only size f right: catalog#00588001602, lot#ni; unknown nexgen tibia size 5: catalog#ni, lot#ni; unknown cement: catalog#ni, lot#ni.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent an initial total knee arthroplasty.Approximately six years and ten months post implantation, the patient experienced a dislocation of the knee while getting up from a chair.Subsequently, the patient underwent revision surgery during which the surgeon noted that the screw fixing the hinge had backed out.The migrated screw and articular surface was exchanged without complication.The patella was also resurfaced and a patellar component was implanted.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; b7; d4; d6a; d10; g3; h2; h4; h10.D10: medical product: femoral component option for cemented use only size f right: catalog#00588001602, lot#11015334; tibial component precoat size 5: catalog#00588000500, lot#63032091; stem extension straight 16mm dia x 100mm length(combined length 145mm): catalog#00598801016, lot#62955353; stem extension straight 10mm dia x 100mm length(combined length 145mm): catalog#00598801010, lot#62937538; palacos r-40g cement: catalog#66017750, lot#81104418, qty#2.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent an initial right total knee arthroplasty.Approximately six years and four months post implantation, the patient experienced a dislocation of the knee while getting up from a chair.Subsequently, the patient underwent revision surgery during which the surgeon noted that the screw fixing the hinge had backed out.The migrated screw and articular surface were exchanged without complication.The patella was also resurfaced and a patellar component was implanted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h10.Visual examination of the returned products identified that the articular surface shows signs of being implanted (gouged, nicked, wear).The returned hinge post extension component showed signs of being implanted; damage to the threads and striations on the shaft.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision records: loosening/disassociation of the screw without trauma, no signs of implant loosening, no hinge fracture, no damage to poly identified, poly exchange and patellar resurfacing performed without complication.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 at time of this report.
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