SYNTHES GMBH FEMORAL NECK SYSTEM IMPLANT KIT/ LENGTH 105MM STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
|
Back to Search Results |
|
Catalog Number 04.168.105S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Stroke/CVA (1770); Pain (1994); Paralysis (1997); Limb Fracture (4518)
|
Event Date 01/01/2022 |
Event Type
Injury
|
Event Description
|
Device report from synthes reports an event in switzerland as follows: it was reported that on (b)(6) 2022, there was a broken 5.0 fns locking screw after pseudoarthrosis and collapse of the femoral neck fracture gap.The patient had a stroke the day after the first surgery on (b)(6) 2022 with hemiplegia of the left side (implant side).Postoperatively, the patient experienced pain.The device was explanted due to hardware failure on (b)(6) 2022.Patient received a hip prosthesis after implant removal.This report involves one femoral neck system implant kit/ length 105mm sterile.This is report 2 of 2 for (b)(4).
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Only the event year is known.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D10: date of concomitant therapy is an unknown date in 2022.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Part #: 04.168.105s, lot #: 165p313, manufacturing site: jabil grenchen, release to warehouse date: 20, may 2021, expiry date: 01, may 2031.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the implkit f/fem neck syst constructl.105, p/n: 04.168.105s, exhibits signs of normal use.The plate (04.168.000), was returned with a broken fragment of the lockscr ø5 self-tap l55 tan (412.220s).No significant product problems were observed on the returned devices.A dimensional inspection was not performed as it is not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the implkit f/fem neck syst constructl.105, p/n: 04.168.105s was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|