ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP
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Model Number N/A |
Device Problems
Material Erosion (1214); Device Dislodged or Dislocated (2923)
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Patient Problems
Necrosis (1971); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unequal Limb Length (4534)
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Event Date 12/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00206; 0001822565-2024-00207.D10: cat# 00625006535, lot# 64001146 ,bone scr 6.5x35 self-tap; cat# 00875705401, lot# 64009913, 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent a revision procedure approximately 5 years post implantation due to the development of pain, limb length discrepancy, instability with recurrent dislocations, and metallosis.During the procedure large gray-black synovial effusion, extensive osteolysis and necrotic lesion of r hip soft tissue with complete loss of hip abductor attachments on proximal femur noted.There was extensive debridement of r hip pseudotumor.Gross black debris around the femoral trunnion, the patient underwent revision, the head and liner components were exchanged without complications.Attempts have been made and no further information has been provided.
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Event Description
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No further information at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: g3; h2; h3; h6.Proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.The patient presented with pain, dislocations, instability, leg length discrepancy, and metallosis.A revision was performed with osteolysis and pseudotumor noted.Black debris was noted on the trunnion.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty without hardware failure or loosening.Patient body habitus does limit evaluation significantly.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.
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