STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE C TAPER TI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
|
Back to Search Results |
|
Catalog Number 19-0000T |
Device Problem
Use of Device Problem (1670)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/26/2023 |
Event Type
Injury
|
Event Description
|
Rep accidentally handed the desk a c-taper sleeve instead of a v40 sleeve.Placed into patient.Notified surgeon and hospital and revision was completed.
|
|
Manufacturer Narrative
|
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
|
|
Manufacturer Narrative
|
Reported event: an event regarding incorrect selection involving an adaptor sleeve was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that a c-taper sleeve was implanted with an accolade ii stem instead of a v40 sleeve.The discovery was made post-operatively, and the patient was revised.The reported event was confirmed via the provided billing sheet.The event is considered to be the result of user error as no manufacturing-related product problem was found given the information provided.It is the responsibility of the surgical team to review the device label prior to implantation.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
Rep accidentally handed the desk a c-taper sleeve instead of a v40 sleeve.Placed into patient.Notified surgeon and hospital and revision was completed.
|
|
Search Alerts/Recalls
|
|
|