Model Number N/A |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/05/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: 010000662 - g7 shell ¿ 6816444.Product has been returned and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that during a hip procedure, the surgeon was unable to seat the liner within the cup after multiples tries.It was confirmed that there was no tissue, bone or screws preventing the successful implanting.A new liner was opened and able to be sat successfully.There was a 30 minute delay due to the liner not seating into the cup.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Visual inspection of the radius has circular indentations on it and the scallops have a scratch on them.The dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Search Alerts/Recalls
|