ZIMMER BIOMET, INC. UNK ACETABULAR COMPONENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
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Catalog Number UNK ACETABULAR COMPONENT |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Scar Tissue (2060); Unequal Limb Length (4534)
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Event Date 02/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00267.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient is status post left total hip replacement with loosening of the acetabular cup, therefore the present procedure was indicated.Leg length was approximately 2cm short on the left compared with that of the right, scar tissue was removed from about the proximal femur.A fractured screw remained and this was removed with the needle driver.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be 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 the patient underwent an initial left total hip arthroplasty on unknown date.Subsequently, the patient was revised approximately eleven (11) months ago due to loosening of the acetabular component and received a pmi device at that time.During the revision, a limb length discrepancy and scar tissue were also noted, as well as a fractured screw that was removed.Attempts have been made and no further information has been provided.
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