Model Number N/A |
Device Problem
Material Erosion (1214)
|
Patient Problems
Ossification (1428); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530)
|
Event Date 04/26/2022 |
Event Type
Injury
|
Event Description
|
It was reported that the patient underwent a revision procedure 16 years post implantation due to pain, elevated metal ion levels and osteolysis.There is no additional information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02503, 0001825034 - 2023 - 02504, 0001825034 - 2023 - 02506.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.
|
|
Event Description
|
It was reported that the patient underwent a revision procedure 16 years post implantation due to to pain, elevated metal ion levels, and osteolysis.During the revision the surgeon did not identify significant metallic staining of the synovium or the surrounding tissue nor an obvious pseudotumor.Corrosion present on the trunnion was noted.The acetabular cup and head were exchanged without complications.There is no additional information available at the time of this report.
|
|
Event Description
|
There is no update to the prior event description provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 mechanical (g04) - head h10 no product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Pre-op diagnosis: right metal on metal total hip arthroplasty with presumed adverse local tissue reaction and elevated serum metal ions.The patient presented with elevated metal ion levels and a mri showing a pseudotumor, combined spinal epidural with periarticular injection, during removal, there was a 2x2 cm cystic defect at the medial aspect of the socket with granulomatous tissue present.There were no intraoperative complications reported.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.
|
|
Search Alerts/Recalls
|