Model Number N/A |
Device Problems
Positioning Failure (1158); Difficult to Insert (1316)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/28/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Item #: unknown head lot #: unknown.Item #: unknown sirius stem lot #: unknown.010000664 g7 pps ltd acet shell 54f 6635233.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03678.
|
|
Event Description
|
It was reported that during an initial total hip replacement using g7 and sirius cemented stem, the g7 liner would not seat after multiple strikes.Had to remove cup with malseated liner.The surgeon impacted a second cup of the same size and 36mm liner without issues.No additional information is available.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|