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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2: foreign: iran.Hadi ravanbod, kaveh gharanizadeh, peyman mirghaderi, ahmad hassan, mansour abolghasemian.(2023) subtrochanteric shortening osteotomy provides superior function to trochanter slide osteotomy in tha for patients with unilateral crowe type iv dysplasia at a minimum of 3 years.Pgs.1-10.Doi 10.1097/corr.0000000000002900.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
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Event Description
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It was reported in a journal article that 5 patients who underwent trochanteric slide osteotomy (tso) sustained a nonunion at the osteotomy site; of which, 3 patients had greater trochanter migration more than 2cm with a moderate limp and positive trendelenburg sign.These patients refused additional surgery.
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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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.It was reported from a journal article that a patient experienced nonunion of the greater tuberosity surgical osteotomy site with migration of the bone which was stabilized with unknown cerclage wires.The femoral hip stem is placed for structural support to the long bone while the cerclage wires are placed for fracture fragment stabilization and union.Long bone fractures follow specific regenerative patterns, creating a complex biological healing process and placing a patient at a heightened risk of delayed union.The healing of bone can be complicated by patient comorbidities such as diabetes, obesity, smoking, level of activity and other conditions that are known to slow a person¿s ability to heal.The given complaint of bone migration after nonunion of the surgical osteotomy site is therefore dependent upon the implanted cerclage wires and unrelated to the implanted femoral stem.Patient bone healing and bone quality concerns are patient-dependent, patient-specific, and multivariate.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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