Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526)
|
Event Date 06/26/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical devices: item# 110018418; lot# unk; hdls cmpn scr 2.5x16 ns.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.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: 0001825034-2021-00818.Remains implanted.
|
|
Event Description
|
It was reported that the patient underwent an initial surgery.Subsequently, the patient was experiencing low foot function and stiffness.Two headless compression screws were implanted in the hallux of the left foot.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
|
|
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 the patient underwent an initial surgery for left foot bunionectomy, osteotomy, and plantar plate repair.Subsequently, the patient reported pain and stiffness leading to an additional surgery.A scar tissue and tendon transfer was performed with implantation of competitor screws.No zimmerbiomet product was removed.The patient did well for 6 months post-op then began experiencing stiffness again in the mtp2.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting patient experienced continued pain after about a year post implantation.Tendinosis and tenosynovitis, recurring of hallux valgus due to metatarsal laxity and a posterior tear with arthrofibrosis mtp2 left foot.Debridement of the necrotic tendon tissue anchoring of tibial tendon, ligaments intact.Dhr was unable to be reviewed as the lot number for the device is unknown.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 further event information available at the time of this report.
|
|
Search Alerts/Recalls
|