Model Number 1506-00-003 |
Device Problems
Loss of or Failure to Bond (1068); Malposition of Device (2616); Migration (4003)
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Patient Problems
Edema (1820); Pain (1994); Synovitis (2094); Injury (2348); Not Applicable (3189); No Code Available (3191)
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Event Date 01/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Reviewed medical records received on (b)(6) 2018.Records indicated patient's left attune knee was revised to address pain, catastrophic varus deformity from implant collapse, and aseptic loosening of the tibial base plate, at the cement to implant interface.Surgeon indicated tibial base plate component was grossly loose.Stated there was tibia bone loss where the tibia was impacted by the loose component.Tibial cement mantle was well-fixed, as was the revised femur component.Indicated that there was mild poly-wear type synovitus.Reported that the patient's native patella had not been resurfaced when the primary was performed.There was no evidence of acute infection.Competitor bone cement used for primary.Doi: (b)(6) 2014; dor: (b)(6) 2017; (left knee).
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Manufacturer Narrative
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Additional narrative: product complaint # = > (b)(4).Investigation summary = > no product associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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(b)(4).These information has been reported in (b)(4) with an mfr number 1818910-2019-112845.Mfr number 1818910-2019-112845 has been retracted due to a duplicate of this mfr report # 1818910-2018-61605.
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Event Description
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Medical records received ad 17 june 2019.The patient underwent a left knee revision due to tibial tray migration, malpositioning, and loosening at the cement to implant interface.The surgeon noted effusion, mild poly wear-type synovitis, and tibial bone loss.The patella was not resurfaced during the primary operation.Competitor cement was used during the primary operation.Doi: (b)(6) 2014; dor: (b)(6) 2017; left knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no product associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: h6.H6 patient code: no code available (3191) was used to capture surgical intervention.
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Search Alerts/Recalls
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