Catalog Number 5537-G-409 |
Device Problem
Device Damaged Prior to Use (2284)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/01/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been one other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
|
|
Event Description
|
It was reported that upon opening the implant, it was noted that there were rivets and dents in the insert.It was reported that the implant appeared damaged.It was reported that a second implant was opened and used for the patient.
|
|
Manufacturer Narrative
|
An event regarding damage involving a triathlon insert was reported.The event was confirmed.Device evaluation and results: material analysis of returned device was performed and indicated that "the damages observed on the tibial insert were consistent with multiple impacts likely with the stabilizing post.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: it was reported that upon opening the implant it was noted that there were rivets and dents in the insert.The reported event confirmed on the basis of visual inspection and material analysis report.The material analysis engineer indicated that damage observed aon the tibial insert were consistent with multiple impacts likely with the stabilizing post.No further investigation is possible at this time , if further information becomes available this investigation will be re-opened.
|
|
Event Description
|
It was reported that upon opening the implant, it was noted that there were rivets and dents in the insert.It was reported that the implant appeared damaged.It was reported that a second implant was opened and used for the patient.
|
|
Search Alerts/Recalls
|