ARTHREX, INC. HUMERAL STEM 9MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number HUMERAL STEM 9MM |
Device Problems
Difficult to Remove (1528); Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)
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Patient Problem
Pain (1994)
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Event Date 01/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that the patient underwent a shoulder "arthoplasty" procedure where a 9mm humeral stem, ar-9100-09 was implanted.After an unknown amount of time, the patient began having persistent pain.A revision surgery was performed on (b)(6) 2019 and the stem, ar-9100-09 was removed.There were two additional implants that were explanted, the stem and the head; however at this time, the part numbers are unknown.The "trunion" from the stem was stuck inside the head and unable to be separated so the rep was not able to read the item number on the head component.The revision was completed with hardware from another manufacturer.
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Manufacturer Narrative
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Complaint was confirmed.Visual evaluation revealed chipping at the end of the inclination block from screw extraction.The metal was noted to be extremely thin and worn down over time.The underside of the trunnion displayed deep circular grooves in the metal, indicating that it had been loose and rotating against the inclination block while in the joint space.Material had been worn away so significantly that the grit blasting was gone and a circular dish has been created on the underside of the trunnion.Minor superficial scratches were noted along the outer diameter of the stem.Damage to the stems inclination block and trunnion is evident of loose components, where over time material was worn away as the trunnion rotated on the inclination block.It should be noted that the universe i system was obsoleted in 2005 and the revision surgery to explant the devices occurred in.
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