ZIMMER, INC. INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY REGULAR RIGHT; PROSTHESIS, SHOULDER
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Model Number N/A |
Device Problems
Material Erosion (1214); Fracture (1260)
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Patient Problem
No Code Available (3191)
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Event Date 08/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is unknown at this time if the device is being returned for evaluation, the investigation has been started and if the device is received, an evaluation will be performed and a follow up will be submitted.Concomitant medical products: catalog number 32810502604, lot number 62790393, interchangeable humeral assembly for cemented use only regular.Multiple mdr reports were filed for this event, please see associated reports: 1822565-2017-01747 & 01776.
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Event Description
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It was reported that the patient underwent a right elbow arthoplasty procedure and approximately fifteen (15) months post-implantation the articulate pin fractured.Subsequently, the patient was revised twenty-one (21) months post-implantation.Operative notes indicated 2 ml of clear synovial fluid discharged from the joint cavity, the pin was destroyed and the polyethylene insert components were worn.The pin and inserts were removed and replaced.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Radiographic evaluation evidenced signs of poly wear and component migration but fracture could not be confirmed.The device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.A definite root cause cannot be determined with the information provided, however, the patient doesn't deny sport activities which may have contributed to event.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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