Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Ossification (1428); Erosion (1750); Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
|
Event Date 09/23/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with screw fixation of the acetabular cup, no wear.No radiolucency.No fracture.Heterotopic ossification formation is present.A definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03231, 0001822565 - 2021 - 02823.
|
|
Event Description
|
It was reported by patient¿s legal counsel reported patient underwent a right hip arthroplasty.Legal counsel further reports patient underwent a revision procedure sixteen (16) years post implantation due to unknown reasons, heterotopic ossification was identified.The femoral head was replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a2; b1; b5; b7; d1; d2; d4; d10; g3; g4; h2; h6.D10: 00801803214-femoral head +7x32mm dia ns-unknown.00620005420-trilogy fm acet shl 54 od univ-60080725.00631005032-liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells-60148580.00625006525-bone scr 6.5x25 self-tap-60127384.00625006525-bone scr 6.5x25 self-tap-60127384.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported patient underwent a revision surgery approximately 15 years post implantation due to pain, swelling, elevated metal, and corrosion.During the procedure a significant amount of fluid was encountered and necrotic tissue in capsule.Iliopsoas tendon erosion and part of the greater trochanter erosion was noted as well as trunnion wear, pitting, staining, black debris.Proximal lysis at femoral stem.Stem was well fixed.A new head and sleeve were placed without any complications.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h6 reported event was confirmed via medical records provided and reviewed by a health care professional.Lot identification is necessary for review of device history records; lot identification was not provided.Additional information does not change the previous root cause.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 additional information on the reported event.
|
|
Search Alerts/Recalls
|