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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Unintended Movement (3026)
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Patient Problems
Host-Tissue Reaction (1297); Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Osteolysis (2377)
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Event Date 02/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.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 a patient was revised due to pain, metallosis, and elevated ion levels approximately 12 years post implantation.It was discovered during the revision that there was corrosion at the taper adapter and stem junction.The stem was retained.Attempts have been made, and no further information has been provided.
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Event Description
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It was reported that the patient underwent a revision procedure approximately eleve and half 11.5 years post implantation due to pseudotumor, loosening, elevated metal ion levels, in vivo corrosion, cyst, osteolysis, impingement, pain, noise, and radiolucency.No further event information available 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.D11: cat#: 01-00214-016, zimmer cup lot#: 2357464.Cat#: 01-00281-540, zimmer head lot#: 2357625.Cat#: 01-00165-146, taper adapter lot#: 2383625.No product was returned; dimensional evaluations could not be performed.Photographs were provided along with medical records.Photographs shows that the shell, head and adapter were removed.No further evaluation possible due to the quality of the images.Medical records were provided and reviewed.Review of the primary operative notes confirms that the patient underwent primary hip arthroplasty on (b)(6) 2007.No complications noted.Office visit notes states left hip pain due to corrosion with occasional grinding in the left hip.Images show a left metal-on-metal hip replacement.There is a circumferential radiolucent line around the acetabular component.Mri-(b)(6) 2018 reviewed and found a fluid collection around the left tha.Patient walks with a trendelenburg to the left side.Revision op notes confirms aseptic loosening acetabular component.Elevated blood and urine cobalt levels.Debridement cystic and solid pseudotumor.Specimens sent: fluid (yellow relatively clear) for cobalt level, aerobic culture, and tissue to pathology to look for adverse reaction to metal debris.Evidence of corrosion between the taper adaptor and large head.This was disassociated from the stemmed trunnion.There was gross corrosion.The durom shell was grossly loose.Reaming¿s were used to graft the cystic areas of lysis.There was significant anterior bone in the proximal femoral area, anterior trochanteric area, which was impinging anteriorly levering the hip posteriorly.Final implants placed without impingement dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information 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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Search Alerts/Recalls
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