STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Catalog Number 626-00-42E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Discomfort (2330)
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Event Date 01/10/2024 |
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.The following devices were also listed in this report: device name# 28 +1 ceramic head ; cat#6570-0-128; lot#99956704.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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It was reported that the patient's left hip was revised due to discomfort and wound drainage.An mdm metal liner, adm/ mdm poly insert, and femoral head were revised.Rep reported that the patient had had an infection, which was cleared by (b)(6) 2024 after the revision.Rep had also been notified by a competitor that a revision previously took place (b)(6) 2023.In that revision, a competitor poly (tri-polar) insert was implanted in an mdm metal liner with a biolox ceramic head.There was no adm/ mdm poly insert in the patient.
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Search Alerts/Recalls
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