EXACTECH, INC. NV GXL LNR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Catalog Number 138-36-52 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Osteolysis (2377)
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Event Date 05/06/2019 |
Event Type
Injury
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Event Description
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It was reported via legal documentation that a patient had a total left hip arthroplasty on (b)(6) 2014, and then approximately 4 years, 9 months later experienced a revision surgery on (b)(6) 2019.Revision operative report of (b)(6) 2019: preoperative diagnoses: 1.Failed left total hip arthroplasty with severe cystic osteolysis and extreme polyethylene wear.2.Subacute posterior pelvic ring fracture through cystic osteolysis.3.Subacute anterior pelvic ring fracture through cystic osteolysis.Procedure performed: 1.Revision left total hip arthroplasty ¿acetabular component revised only via separate incision.2.Open reduction, internal fixation of left posterior pelvic ring fracture via separate incision.3.Open reduction, internal fixation of left anterior pelvic ring fracture via separate incision.Throughout the posterior aspect of the hip joint, particularly around the posterior column, there was reactive material consistent with cystic osteolysis and particulate disease.The posterior pelvic bone was very thin.The polyethylene in the acetabulum.It was severely eccentrically worn.There was an anterior lip and this lip was partially damaged and partially destroyed due to anterior impingement from the neck of the stem.In addition, there was severe eccentric wear.The thickness of the thinnest portion of the polyethylene was not more than a millimeter and, in some places, thinner than a millimeter.Removed the 54mm exactech socket quite easily with the explant (there were minimal areas of ingrowth).The cystic osteolysis membrane was removed.The acetabular cysts were curetted down to bleeding bone.Open reduction and internal fixation of the posterior pelvic ring fracture and the anterior pelvic ring fracture.The patient was taken to the recovery room in a stable manner.In the recovery room, he had active dorsiflexion of his left ankle and calf indicating the sciatic nerve was functional and functioning well.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
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Manufacturer Narrative
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H10.D10.Concomitants: (b)(6), 120-65-20 - bone screw 6.5mm dia x 20mm long; (b)(6), 120-65-25 - bone screw 6.5mm dia x 25mm long; (b)(6), 142-36-00 - cocr fem head 36mm +0 offset 12/14; (b)(6), 164-11-10 - novation element ro s/o sz 10; (b)(6), 180-01-54 - nv crown cup clstr hole 54mm group 2.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.
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Manufacturer Narrative
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H10.H6.Investigation results- based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified in (b)(6).However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.There is no other information available.
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