UNKNOWN UNCEMENTED PRESS-FIT RHEAD STEM

Additional Manufacturer Narrative

THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF A STUDY FROM A HOSPITAL IN (B)(6). THE TITLE OF THIS REPORT IS ¿SHORT- TO MID-TERM RESULTS OF METALLIC PRESS-FIT RADIAL HEAD ARTHROPLASTY IN UNSTABLE INJURIES OF THE ELBOW¿ WHICH IS ASSOCIATED WITH THE STRYKER RHEAD SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN 2002 AND 2010. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 13 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REMOVAL OF RHEAD PROSTHESIS DUE TO LOOSENING. 4 OUT OF 7 CASES. THE REPORT STATES: ¿AT THE FINAL FOLLOW-UP 25 PROSTHESES WERE WELL FIXED; NINE LOOSE PROSTHESES HAD BEEN REMOVED (SIX RHEAD, THREE ACUMED; THREE IN ASSOCIATION WITH A CONTRACTURE RELEASE, FIVE OWING TO LATERAL-SIDE ELBOW PAIN, AND ONE BECAUSE OF PAIN AND OBVIOUS CREPITUS), AND THREE WERE LOOSE (ONE RHEAD, TWO ACUMED). RADIOLUCENT LINES WERE ASSESSED BEFORE REMOVAL OF THE PROSTHESIS AS MILD IN THREE, MODERATE IN ONE, AND SEVERE IN FIVE PATIENTS.¿