MCREYNOLDS IMPACTOR ADAPTER
Received May 3, 2016 · Event occurred Apr 7, 2016
Report 0002249697-2016-01499 · MDR key 5629039
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous
Manufacturer
Stryker Orthopaedics-mahwahCatalog number
6260-4-090
Lot number
TDEN403
Product problems
- Break
Patient
69 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
THREADS ON THE MCREYNOLDS DISTAL STEM ADAPTER BROKE OFF IN THE CONICAL DISTAL STEM AS SURGEON WAS ATTEMPTING TO REMOVE THE STEM FROM THE CANAL.
Additional Manufacturer Narrative
REPORTED EVENT: AN EVENT REGARDING FRACTURE INVOLVING A MCREYNOLDS ADAPTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: EXAMINATION OF THE DEVICE CONFIRMED THE EVENT AND DETERMINED THE DEVICE FRACTURED IN OVERLOAD. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW: THERE WERE NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE EXAMINATION OF THE DEVICE INDICATED THE THREADS FRACTURED DUE TO OVERLOAD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
THREADS ON THE MCREYNOLDS DISTAL STEM ADAPTER BROKE OFF IN THE CONICAL DISTAL STEM AS SURGEON WAS ATTEMPTING TO REMOVE THE STEM FROM THE CANAL.