Catalog Number 30600090S |
Device Problems
Break (1069); Component Falling (1105); Noise, Audible (3273)
|
Patient Problems
Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Pain (1994)
|
Event Date 06/20/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
|
|
Event Description
|
Patient is currently in constant pain in her right hip.Patient has welts on her hip that are hot to touch and painful.Patient can hear audible clicking/popping sounds.Patient's primary surgery was in (b)(6) 2014.On (b)(6) 2015 is was found that the rod fell in the leg, fractured the femur and opened up an old fracture.Patient had a revision in (b)(6) 2015 in which all parts were removed due to malfunction of hardware (as per surgeon).Patient is currently in a lot of pain and in need of a total hip replacement.Updated: received additional information: it was reported that rod fell in patient铠leg.Top portion of where the bolt was broken.It was reported that patient did not fall.It was alleged that patient is allergic to some metals.
|
|
Manufacturer Narrative
|
Evaluation revealed that the item did not contribute to the complained event, therefore it was classified as concomitent item.Details of the evaluation are attached in investigation for the primary product.
|
|
Event Description
|
Patient is currently in constant pain in her right hip.Patient has welts on her hip that are hot to touch and painful.Patient can hear audible clicking/popping sounds.Patient's primary surgery was in (b)(6) of 2014.On (b)(6) 2015 is was found that the rod fell in the leg, fractured the femur and opened up an old fracture.Patient had a revision in (b)(6) of 2015 in which all parts were removed due to malfunction of hardware (as per surgeon).Patient is currently in a lot of pain and in need of a total hip replacement.Updated: received additional information: it was reported that rod fell in patient¿s leg.Top portion of where the bolt was broken.It was reported that patient did not fall.It was alleged that patient is allergic to some metals.
|
|
Search Alerts/Recalls
|