STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TIBIAL DEVICE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 07/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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Event Description
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Based on the clinicians's medical review comments for pi (b)(4), "a second revision of the left knee was consequently performed on (b)(6) 2016, for ¿gross loosening of patellofemoral and tibial device¿ as reported in the records.All left knee devices were removed and replaced with biomet cemented revision devices with a satisfactory clinical result.".
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Search Alerts/Recalls
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