ZIMMER BIOMET, INC. LINER STANDARD 32 MM I.D. FOR USE WITH 58 MM O.D. SHELL; PROTHESIS, HIPS
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Model Number N/A |
Device Problems
Material Erosion (1214); Naturally Worn (2988)
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Patient Problems
Necrosis (1971); Pain (1994); Metal Related Pathology (4530)
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Event Date 07/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 00771101200 ml taper sz12.5 std offset 60753334 00620205822 tm acet shell 58mm cluster 60629168 00801803202 femoral head sterile product do not resterilize 12/14 taper 60780515 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the patient had a right total hip arthroplasty.Subsequently, the patient underwent a revision surgery nine (9) years post implantation due to pain and elevated metal ions.The femoral head and liner were revised.During the revision procedure, pseudocapsule, implant corrosion, and bone loss was noted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6 visual examination of the returned product/provided pictures identified the taper of the femoral head exhibits a circumferential groove pattern and dark debris.The poly liner shows damage on the backside of the rim.A portion of the rim is chipped and missing.The stem remains implanted.The head was submitted for further analysis.Analysis determined fretting on >10% of the surface and/or corrosion damage to one or more small areas.Review of the device history records identified no deviations or anomalies during manufacturing for the liner.Root cause unchanged.This complaint was confirmed based on the returned devices and medical records.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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Event Description
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No additional event information to report at this time.
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