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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Necrosis (1971); Pain (1994); Local Reaction (2035); Joint Dislocation (2374)
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Event Date 08/31/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: femoral head sterile product do not resterilize 12/14 taper, pn 00801803602, ln 61297194 liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell, pn 00630505636, pn 61211893.Shell porous with cluster holes 56 mm o.D., pn 00620005622, ln 61176487.Kinectiv modular femoral stem , pn 00771301500, ln 60845836.This event was initially reported on 0001825034-2019-03798.Multiple mdr reports were filed for this event, please see associated reports 0002648920-2019-00731, 0001822565-2019-04374.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 that patient underwent revision approximately 7 years post initial implantation due to dislocation, instability, necrosis, elevated metal ion levels, pain, adverse tissue reaction, tissue damage including abduction muscles were noted to be devoid to trochanter and corrosion.Patient dislocated 4 times prior to the revision procedure and the surgeon noted this was attributed to the abductor tissue necrosis.The head, neck, liner and shell were removed and replaced.The shell and liner were replaced with competitor products.Attempts were made to obtain additional information; however, none was available.
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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.D4: udi number: (b)(4).Reported event was confirmed by review of medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes were reviewed and no complications were noted.Revision op notes were reviewed and identified the patient was revised due to elevated ions.Necrotic tissue, tissue damage including abduction muscles were noted to be devoid to the trochanter.4 posterior dislocations of the right hip.Instability noted.Normal colored joint fluid encountered.Necrosis; debridement performed.The noted mid-portion of the greater trochanter and posterior border of greater trochanter lacked tissue attachments.Acetabular component good position ¿ explanted.Recurrent dislocations felt to be related to abductor tissue necrosis vs.Malpositioning.Revision of trilogy acetabular component to stryker mdm component to compensate for damaged abductor mechanism.Head removed black metal debris within cobalt chrome head.No corrosion noted at neck/body junction.The femoral component stable good position, well fixed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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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