Model Number N/A |
Device Problem
Component or Accessory Incompatibility (2897)
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Patient Problem
Tissue Damage (2104)
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Event Date 12/11/2008 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-04215 / 04216).
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Event Description
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Legal counsel for patient reported that patient underwent a right hip revision procedure approximately seven years post implantation.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Operative reports provided noted that during primary implantation a 10mm stem was attempted to be implanted, however, it sat proud.After attempting to resolve the issue through neck resection and using a high speed bur to take off some bone of the medial calcar, the stem was removed and the procedure was completed with a 9mm stem.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.Concomitant products: m2a-magnum modular head: catalog#: 157442, lot#: 958820.M2a-magnum pf cup: catalog#: us157848, lot#: 479180.M2a-magnum taper adapter: catalog# 239254, lot# 481660.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.Concomitant medical product - unknown biomet head, unknown biomet cup, unknown biomet liner.
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Search Alerts/Recalls
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