STRYKER GMBH #3 BIPOLAR STEM IMPLANT (STERILE PACKED); PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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Model Number RCN-S3 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348)
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Event Date 12/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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The information in this report was provided by stryker legal affairs.No additional information is available at this time.Therefore, the exact cause of the reported event cannot be determined.Device not available.
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Event Description
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It's reported that the patient underwent a right stryker lateral assembly radial head and stem elbow implant implanted on (b)(6) 2011.After implantation, the patient began to experience pain, decreased function and instability of his right elbow.After images showed loosening of the components, the patient underwent revision surgery on (b)(6) 2019.
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Manufacturer Narrative
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Correction: refer to a2, h6 patient code.
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Event Description
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It's reported that the patient underwent a right stryker lateral assembly radial head and stem elbow implant implanted on (b)(6) 2011.After implantation, the patient began to experience pain, decreased function and instability of his right elbow.After images showed loosening of the components, the patient underwent revision surgery on (b)(6) 2019.
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