STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_POLY LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Injury (2348)
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Event Date 07/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Catalog numbers and lot codes of other devices listed in this report: unknown ceramic head, unknown lot it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
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Event Description
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It was reported the patient's hip was revised 2 weeks post implant due to suspected infection.Surgeon performed an incision and drainage with a head and liner exchange.A ceramic head was revised to an lfit metal head and the poly insert was exchanged for another insert of the same catalog number.Rep may be able to provide catalog number and lot codes for the revised implants, but confirmed that otherwise, no further information will be released.
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