Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
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Event Date 02/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: hartford j.M., graw b.P, frosch d.L.(2022) reduced incidence of perioperative periprosthetic fractures using hybrid rasp-impaction broaching over impaction broaching when using the direct anterior approach for total hip arthroplasty.Arthroplasty today vol.15 (2022) 75-80 https://www.Arthroplastytoday.Org/article/s2352-3441(22)00069-3/fulltext.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.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 patient experienced an intertrochanteric fracture due to wedging of the implant postoperatively.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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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.H6 component code: mechanical (g04)- stem.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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 additional information on the reported event.
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Event Description
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It was reported patient experienced an intertrochanteric fracture due to wedging of the implant postoperatively.Surgeon believed osteoporosis and excessive hoop forces produced by implant caused the fracture.Patient used protected weight bearing to address the fracture.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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Final: this follow-up report is being submitted to relay additional information.Additional information received from surgeon does not change previously found root cause.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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