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Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Host-Tissue Reaction (1297); Ossification (1428)
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Event Date 10/09/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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Information was received based on the journal article entitled, delayed dislocation following metal-on-polyethylene arthroplasty of the hip due to ¿silent¿ trunnion corrosion.The aim of the article was to present a case series of ten metal-on-polyethylene total hip arthroplasties (mop thas) with delayed dislocation associated with unrecognized adverse local tissue reaction due to corrosion at the trunnion and pseudotumour formation.It was reported that a patient was revised 52 months after surgery due to dislocation, pseudotumour, taper corrosion and ho brooker gd 1.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The reported event occurred in (b)(6).Medical products - unknown continuum acetabular liner, unknown trilogy acetabular cup, unknown 36 mm femoral head, all catalog#'s: ni all lot's#: ni.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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 contribute to monitor for trends.
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Event Description
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It was reported in a journal article received that patient underwent a hip revision procedure approximately 52 months post-implantation due to three dislocations, pseudotumor formation, taper corrosion and brooker grade 1 heterotopic ossification.No additional patient consequences were reported.
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Search Alerts/Recalls
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