Model Number 1506-10-008 |
Device Problems
Failure To Adhere Or Bond (1031); Loss of or Failure to Bond (1068)
|
Patient Problems
Adhesion(s) (1695); Pain (1994); Not Applicable (3189); No Code Available (3191)
|
Event Date 05/10/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Der states patient came to see the surgeon complaining of knee pain since his primary knee was implanted.The surgeon decided to take him to surgery to check components for loosening.The femoral component was stable but the tibial component was loose at cement to implant interface and needed to be revised.The surgeon commented that the tibial component did not have any cement on the underside.The original tibial component had been implanted with depuy ghv bone cement but unable to get lot # since the hospital buys their cement directly from depuy.He removed all the cement from tibia and implanted attune rev tray sleeve and stem.He replaced with an appropriate size poly.Doi: (b)(6) 2017.Dor: (b)(6) 2018.Left knee.
|
|
Manufacturer Narrative
|
(b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Pc-(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Medical records received on 14 jan 2020 were reviewed to identify patient harms/product issues on 27 jan 2020.The patient underwent a left knee revision due to pain and tibial tray loosening at the cement to implant interface.The femoral and patellar components were retained.The surgeon noted excising scar tissue around the patella, patellar tendon, quadriceps tendon, back of knee, and suprapatellar pouch and gutters.Two depuy cement products were used during the primary operation.Doi: (b)(6)2017 dor: (b)(6)2018 left knee.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. h10 additional narrative: added: a2, b5, d4, d11, h6 (no code available (3191) is used to capture the surgical intervention and medical device removal).Corrected: a1, b3.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
|
|
Manufacturer Narrative
|
Product complaint (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.H10 additional narrative:.
|
|
Search Alerts/Recalls
|