Model Number 1506-10-004 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Synovitis (2094); Osteolysis (2377); Not Applicable (3189); No Code Available (3191)
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Event Date 12/13/2017 |
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 (b)(6) 2018.Right knee tibia revised to address painful instability, osteolysis, and aseptic loosening of the tibial base plate.Revising surgeon identified significant synovitus, and indicated that the tibia component came out with little resistance, and that there was no bonding of the bone cement to the back side of the tibial base plate.The surgeon also noted that the cement was well bonded to the actual bone surface of the tibia.Osteolysis was identified in the proximal medial tibia.Femoral and patellar components were not revised.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthese considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: b1, h6 (patient).H6 patient code: no code available (3191) was used to capture joint instability and surgical intervention.
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Search Alerts/Recalls
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