Model Number 5001-0301N-S |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
Additional mdrs associated with this event: mdr 3025141-2016-00131: head, mdr 3025141-2016-00133: stem.
|
|
Event Description
|
A slide-loc anatomic radial head was implanted on (b)(6) 2016.At a follow up appointment (approximately five weeks after implantation), x-rays showed that the head/neck assembly had partially disassociated from the stem some time post-operatively.Revision surgery has not been scheduled.
|
|
Manufacturer Narrative
|
Additional mdrs associated with this event: mdr 3025141-2016-00131: head follow up 1.Mdr 3025141-2016-00133: stem follow up 1.
|
|
Manufacturer Narrative
|
The returned head, neck and stem parts were examined under magnification and with the naked eye.The head and neck implants were assembled when received.The laser lines on the head and neck were misaligned by about 13 degrees preventing the head/neck assembly from rotating the full 45 degrees when locking onto the stem.The locking intreface region on the neck implant was damaged.Damage to the interface was most likely caused by the stem clamp not being fulled seated on the stem prior to rotation to lock.
|
|
Event Description
|
Revision surgery to remove the implants occurred on (b)(6) 2016.
|
|
Manufacturer Narrative
|
Additional mdrs associated with this event: 3025141-2016-00131 follow up 3: head.3025141-2016-00133 follow up 3: stem.
|
|
Search Alerts/Recalls
|