(b)(4).D10 - associated medical devices: tprloc 12/14 por lat 11x142; item# 650-0264; lot# 1476477.M2a-magnum recap cup 56odx50id; item# 157856; lot# 1488514.M2a-magnum mod hd sz 50mm; item# 157450; lot# 1505536.G2 - foreign: italy.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.2 months post op; labs (third part medical records.Pdf pg.33).Cobalt 75.77 (normal <1.0).Chromium 37.86 (normal <1.0).6 months post 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 13 months post op; revision (third part medical records.Pdf pg.1).Left revision total arthroplasty metal on metal with necrosis.No revision op report provided.13 months post op; 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.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.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.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 for this product, a supplemental report will be filed accordingly under mdr report number: 0001825034-2024-01142.Zimmer biomet will continue to monitor for trends.
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