ZIMMER BIOMET, INC. LINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL; PROSTHESIS, HIP
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Information (3190)
|
Event Date 11/30/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001822565 - 2017 - 08631, 0001822565 - 2017 - 08632, 0001822565 - 2017 - 08633, 0001822565 - 2017 - 08634.(b)(4).Concomitant medical products: 00875200932, liner elevated rim 32 mm o.D.Size hh for use with 50 mm o.D.Size hh shell, lot 63725435.00875304801, shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners, lot 63421517.00875305001, shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners, lot 63598550.00875305001, shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners, lot 63379166.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 procedure the cup could not be stabilized and a liner could not be impacted after several attempts.This event caused 90 minutes delay.No further information has been made available at this time.
|
|
Manufacturer Narrative
|
Cmp-(b)(4).This follow-up report is being submitted to relay additional information.Updated: complaint sample was evaluated and the reported event was confirmed.Product was returned for evaluation.As returned, device show damages from the failed attempts to install.Device history record dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 further event information available at the time of this report.
|
|
Manufacturer Narrative
|
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 right hip procedure the cup could not be stabilized.The liner would not seat after impacted, the liner was removed, cleaned, dried, and implanted again, the liner would not seat completely.The cup was taken out impacted on the operating table, still would not seat.The surgeon tried implanting a new cup, the liner would not seat in the cup after trying several times.Finally, the surgeon had to remove the cup and screws and use a new larger cup and correspond liner to complete the surgery.This event has caused 90 minutes delay.
|
|
Search Alerts/Recalls
|
|
|