Model Number N/A |
Device Problems
Biocompatibility (2886); Patient Device Interaction Problem (4001)
|
Patient Problems
Pain (1994); Synovitis (2094); Metal Related Pathology (4530)
|
Event Date 10/24/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10 - m2a-magnum mod hd sz 50mm, item# 157450, lot# 1505536; tprloc 12/14 por lat 11x142, item# 650-0264, lot# 1476477; magnum tpr adpr ti 42- 50/+8mm, item# 130832, lot# 1338003.G2 ¿ foreign ¿ italy.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|
|
Event Description
|
It was reported that a patient underwent an initial left mom hip surgery.Approximately nine years post-implantation follow up examinations resulted in elevated metal ion levels.Due diligence is in progress for this complaint; to date no additional information or product has been received.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the available information, a definitive root cause cannot be determined.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 available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|
|
Manufacturer Narrative
|
(b)(4), this follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Medical records were provided and reviewed by a health care professional.The review identified the following.10 years post initial op; labs (third part medical records.Pdf pg.33).Cobalt 75.77 (normal <1.0).Chromium 37.86 (normal <1.0).10 years and 5 months post initial op; consult (third part medical records.Pdf pg.31) the patient is examined for increase in metal ions in pta mom.Mri of the pelvis is required but left pta revision surgery is recommended 11 years and 1 month post initial op; revision (third part medical records.Pdf pg.1) left revision total arthroplasty metal on metal with necrosis no revision op report provided.1 days post revision; pathology report (third part medical records.Pdf pg.3).Diagnosis: fragments of detrital synovitis, fragments of medullary bone with extensive intertrabecular infiltration by phagocytosing histiocytes, likely prosthetic material, fragments of detrital synovitis.With the available information, a definitive root cause cannot be determined.Moving forward, if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly under mdr report number: 0001825034-2024-01144.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|