ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER SIZE 9 STANDARD OFFSET REDUCED NECK LENGTH; PROSTHESIS, HIP
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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 01/04/2021 |
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.Concomitant medical products: part: 00801803202, lot: 61634940, femoral head 12/14 taper.Part: 00631005032, lot: 61540437, liner 10 degree elevated rim 32 mm i.D.Part: 00620205222, lot: 61471540, shell porous with cluster holes 52 mm.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00348.
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Event Description
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It was reported a patient underwent an initial left total hip arthroplasty performed and subsequently, the patient was revised 11 years later due to pain and elevated metal ions.During the revision, minimal tissue reaction was encountered.Minimal corrosion was noted and cleaned from the trunnion.Only the femoral head was exchanged.Attempts have been made and no further information has been provided.
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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 information.Updated: reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records reviewed by a health care professional identified the following: an initial left tha was performed.The patient was revised due to elevated metal ions and pain.The patient previously had a revision of the right hip for elevated metal ions, but the cobalt level did not return to 0.Within the joint, the capsule was noted to be thick, and minimum tissue reaction and corrosion found.Only the head was replaced with zimmer products.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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