Catalog Number 4003940002 |
Device Problems
Naturally Worn (2988); Therapeutic or Diagnostic Output Failure (3023); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930)
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Event Date 06/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item number: 00598605702; item name : non-augmentable stemmed tibial component option size 8; item batch: 62133498; handled in (b)(4); item number: 00596401751; item name: femoral component option size g left; item batch: 62254530; handled in (b)(4); item number: 00596405010; item name: articular surface size gh 10 mm height; item batch: 62412557; handled in (b)(4); item number: 00597206538; item name: all poly patella size 38 mm dia.Standard 9.5 mm thickness; item batch: 62413073; handled in (b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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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Event Description
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It has been reported that it has been reported that a revision due to infection was performed following a total left knee replacement on (b)(6) 2018, and a spacer k and 4 grams of vancomycin with cement was placed during this revision surgery.The second stage revision was planned on (b)(6) 2018 to remove the spacer and to place the implant.It was noticed an implant loosening with evidence of wear of the polyethylene insert and evidence of device pitting.
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Search Alerts/Recalls
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