BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
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Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Subluxation (4525); Joint Laxity (4526)
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Event Date 09/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: g7 osseoti 3 hole shell 48mm c; (b)(4); lot#65571969, trilogy bone scr 6.5x35; (b)(4); lot#j7448916, trilogy bone scr 6.5x20; (b)(4); lot#65840540, g7 vit e neutral lnr 32mm c; (b)(4); lot#64874029, tprlc 133 fp type1 pps so 8.0; (b)(4); lot#6137651, pr std st/oss lh cp/ve ln cer; (b)(4); lot#unknown.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.
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Event Description
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It was reported as initial right total hip arthroplasty.Subsequently revised due to subluxation and instability.During the revision posterior impingement, acetabular component not in a functional position, and joint laxity.The stem was well fixed and remained implanted.The acetabular shell, liner, and head were exchanged without complication.Approximately 85 days post-implantation.Attempts have been made and all additional information received has been included in this report.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected 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.The device is used for treatment.Radiographs were provided and reviewed by a radiologist.Right hip arthroplasty with anatomic alignment and no acute abnormality.There is suspected excessive cup anteversion as noted which may be associated with recurrent subluxation and dislocation.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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