Catalog Number 00235710114 |
Device Problem
Fracture (1260)
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Patient Problems
Adhesion(s) (1695); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)
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Event Date 09/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign - event occurred in (b)(6).Other - reported by (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Event Description
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It was reported by (b)(6) that a patient was revised approximately two (2) years post-implantation due to implant fracture.Patient was experiencing pain but no other symptoms, and it is unknown what caused the implant to fracture.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 were updated/corrected: a1; a2; a3; a4; b3; b4; b5; b7; d6; e1; e2; e3; g2; g3; g6; h1; h2; h6.The investigation is still in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Event Description
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No further event information available at the time of this report.
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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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This follow-up report is being submitted to relay additional information.D10: item# 23595055; lot# 63618315.Item# 23594055; lot# 63067675.Item# 23595555; lot# 63108308.Item# 23595555; lot# 63807237.Item# 23595555; lot# 63807237.Item# 484532; lot# 62716313.Item# 484514; lot# 62073572.Item# 23595555; lot# 64071049.Item# 23595555; lot# 64071049.Item# unk screw; lot# unk.Item# unk screw; lot# unk.Visual examination of the returned product identified a zplp bone plate (lot 64302552) was returned.As returned, the plate is fractured.The fracture runs through a threaded hole.Surface damage (nicks & scratches) is seen throughout the entire length of the plate.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: prior to revision during an office visit, it was noted there was no pain, wound healed well.Xray shows healing fracture with no displacement.X-ray report showed osteosynthesis by screwed plate along fracture of the lower extremity of the femur (pt has had a total knee and hip prosthesis).Revision occurred.General anesthesia used.Previous incision utilized, encountered scar tissue.Cancellous bone excised from iliac crest to mix with tbf bank tissue for bone defect in the pseudoarthrosis area.Competitor products placed with stabilization.No complications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information 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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Search Alerts/Recalls
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