Catalog Number 574101060 |
Device Problems
Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
|
Patient Problems
Wound Dehiscence (1154); Bone Fracture(s) (1870); Pain (1994); Seroma (2069); Ambulation Difficulties (2544)
|
Event Date 08/31/2021 |
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent an initial left total hip arthroplasty.Approximately two (2) weeks post-implantation, the patient experienced a twisting motion of the left leg which resulted in severe pain and an inability to walk.Diagnostic images revealed a periprosthetic trochanteric fracture and subsidence of the femoral stem.Subsequently, the patient underwent an uncomplicated fracture reduction procedure with revision of the femoral head and stem components.Due diligence is in progress for this event; to date no further information has been reported.
|
|
Manufacturer Narrative
|
(b)(4).D10: medical product: sulox-head 28 l 12/14: catalog#17.28.07, lot#3052661l20dural alpha insert w rim gg/28: catalog#01.00013.307, lot#3065509;allofit-s alloclas shell 48/gg: catalog#4263, lot#3065411.G2: foreign: germany.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
|
|
Event Description
|
No further event information at time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections have been updated: a2; b4; b5; b7; g3; h2; h11.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.H6: proposed component code: mechanical (g04)- stem visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left total hip arthroplasty was performed.Two weeks later, a twisting trauma of the leg resulted in pain.A periprosthetic fracture was identified with subsidence.The stem was found loose and was removed, the fracture was reduced with cables.The head and stem were explanted and replaced with zb product.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial anatomic alignment of the left hip arthroplasty complicated by a periprosthetic femoral fracture.Subsequent revision with fracture fixation and anatomic alignment.Subsequent imaging demonstrates a new cone fracture as described.Root cause was unable to be determined however it was reported the patient sustained a twisting motion leading to the fracture and subsidence.Investigation results concluded that no device problem was found related to the seroma and wound complication as procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management reported event was confirmed by review of provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information at time of this report.
|
|
Search Alerts/Recalls
|