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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Metal Shedding Debris (1804)
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Patient Problems
Host-Tissue Reaction (1297); Fatigue (1849); Nausea (1970); Necrosis (1971); Pain (1994); Local Reaction (2035); Discomfort (2330); Sleep Dysfunction (2517); Limited Mobility Of The Implanted Joint (2671)
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Event Date 04/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Implant date - unknown date in (b)(6) 2013.Explant date - unknown date in (b)(6) 2017.Medical devices: unk, unknown trilogy cup, unk, unk, unknown trilogy liner, unk, unk, unknown head, unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06124, 0001822565 - 2017 - 06125, 0001822565 - 2017 - 06126.
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Event Description
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It was reported patient underwent a right hip arthroplasty on an unknown date.Subsequently, patient was revised on an unknown date due to discomfort, pain, nausea, fatigue, difficulty walking, difficulty sleeping, elevated metal ion levels, tissue and muscle necrosis, and pseudotumors.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to not be reportable.There are no allegations of failure of the device and the initial report was submitted in error.
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Manufacturer Narrative
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(b)(4).Medical products: 00801803202, femoral head, 62406682; 00630505632, liner, 62343880; 00620205622, shell porous, 62283213; 00625006540, bone screw, 62204958; 00625006525, bone screw, 62437498.Surgical noted indicated an abundance of cloudy purulent-appearing fluid under tension which was decompressed.There was also evidence of muscle and capsular necrosis involving more than 50% of the abductor muscle.The head was removed.The taper was examined and showed extensive evidence of corrosion in the form of blackened metallic debris.Necrotic tissue was removed from around the acetabulum.The liner was removed, and there was evidence of deformation of the backside where the liner was in contact with the central hole in the shell.The acetabular component (cup) was well fixed.The femoral (stem) was well fixed.The taper was cleaned.X-rays were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history and adherence to rehabilitation protocol are unknown dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event was 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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Event Description
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It was reported that a patient underwent a right initial total hip arthroplasty due to unknown reasons.After the initial procedure the patient developed pain, elevated metal ion levels, discomfort, and required a revision in her right hip.During the procedure it was noted that there was an abundance of cloudy purulent-appearing fluid under tension which was decompressed.There was also evidence of muscle and capsular necrosis involving more than 50% of the abductor muscle.The head was removed.The taper was examined and showed extensive evidence of corrosion in the form of blackened metallic debris.Necrotic tissue was removed from around the acetabulum.The liner was removed, and there was evidence of deformation of the backside where the liner was in contact with the central hole in the shell.The acetabular component (cup) was well fixed.The femoral (stem) was well fixed.The taper was cleaned.Attempts have been made and no further information is available at this time.
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Search Alerts/Recalls
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