ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT; PROSTHETIC, HIP
|
Back to Search Results |
|
Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
|
Patient Problems
Necrosis (1971); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)
|
Event Date 06/08/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: item# 00620205022 | item name shell porous with cluster holes 50 mm | lot #61315203.Item# 00631005032 | item name liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells | lot #61294026.The device will not be returned for analysis as remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00506.
|
|
Event Description
|
It was reported by legal patient underwent initial right tha.Patent was subsequently revised eleven (11) years later due to elevated metal ion levels, altr, pain, necrosis, in-vivo corrosion, and pseudocapsule.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565-2020-02304.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565-2020-02304.
|
|
Search Alerts/Recalls
|
|
|