POLYSULFONE COMPOSITE HIP STEM STEM-RD105413

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for POLYSULFONE COMPOSITE HIP STEM STEM-RD105413 manufactured by Biomet Inc..

Event Text Entries

[21701966] Hip stem broke at neck body junction in spiral fashion while skiing. Removed & replaced w/metal revision prosthesis. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number4565
MDR Report Key4565
Date Received1992-07-01
Date Added to Maude1993-05-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePOLYSULFONE COMPOSITE HIP STEM
Product CodeKMC
Date Received1992-07-01
Model NumberSTEM-RD105413
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key4284
ManufacturerBIOMET INC.

Patients

Patient NumberTreatmentOutcomeDate
101. No Informationnvalid Deathata 1992-07-01
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