(b)(4).D10 - associated medical devices: g7 pps ltd acet shell 50d; item# 010000662; lot# 7067118.Tprlc 133 fp type1 pps ho 5.0; item# 51-101050; lot# 3799117.32mm i.D.Size d neutral liner; item# 30103204; lot# 64922381.Bone screw self-tapping 6.5 mm dia.25 mm length; item# 00625006525; lot# j7053823.Unknown apical hole plug; item# unknown; 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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It was reported the patient underwent an initial right total hip arthroplasty.Subsequently, following a fall due to unknow reasons, the patient visited the emergency room approximately one year and two months post the initial surgery.The patient was experiencing pain and difficulty with mobility.Imaging diagnosed a contusion and medication was given for pain management.Attempts have been made and no further information is available.
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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.Medical records were provided and reviewed by a health care professional.The review identified: patient presented to er with acute exacerbation of hip pain after a fall 2 days prior, pain is worsening and radiates, patient has been using a crutch to assist her.On exam no deformity, leg shortening, or neurovascular deficit, rom intact.Ct performed due to poor mobility despite negative x-rays-also negative, no evidence of loosening or fracture.Diagnosed with contusion (bruise), resolved with elevation and icing.With the available information, a definitive root cause could not 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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