SKELETAL DYNAMICS

Description of Event or Problem

A PATIENT WAS EXPERIENCING PAIN FOLLOWING IMPLANTATION OF A STABLYX CMC DEVICE, REQUIRING REMOVAL SURGERY.

Additional Manufacturer Narrative

THE INSTRUCTIONS FOR USE FOR THE STABLYX CMC ARTHROPLASTY SYSTEM INCLUDES MULTIPLE WARNINGS AND PRECAUTIONS, INCLUDING THE FOLLOWING POTENTIALLY RELATED STATEMENTS: "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT, OR FIXATION OF THE IMPLANTS MAY RESULT IN UNUSUAL STRESS CONDITIONS, WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS, POSTOPERATIVE COMPLICATIONS, OR INEFFECTIVE TREATMENT." "MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE PROSTHESIS OR ANATOMICAL STRUCTURES." "FOR SAFE AND EFFECTIVE USE OF THE IMPLANT, THE SURGEON MUST BE THOROUGHLY FAMILIAR WITH THE SURGICAL TECHNIQUE FOR THE DEVICE, IMPLANT, AND ASSOCIATED INSTRUMENTS. IMPROPER INSERTION OF THE DEVICE DURING IMPLANTATION MAY ALSO INCREASE THE POSSIBILITY OF LOOSENING, MIGRATION AND FAILURE OF THE DEVICE OR THE TREATMENT." "THE DEVICE IS NOT DESIGNED TO WITHSTAND THE STRESS OF WEIGHT BEARING, LOAD BEARING, OR EXCESSIVE PHYSICAL ACTIVITY. DEVICE LOOSENING, BONE OR SOFT TISSUE INJURY MAY OCCUR WHEN THE IMPLANT IS SUBJECTED TO EXCESSIVE LOADING." "POTENTIAL STABLYX CMC ARTHROPLASTY SYSTEM CONSTRUCT FAILURES, SUCH AS STRESS FRACTURES OF THE BONES, LOOSENING OF THE CONSTRUCT AND/OR FIXATION, SUBSIDENCE, SOFT TISSUE IRRITATION, OR INCOMPLETE HEALING, MAY OCCUR AS A RESULT OF NON-COMPLIANCE WITH POST-OPERATIVE REHABILITATION, EXCESSIVE ACTIVITIES, OR CONSTRUCT OVERLOADING." "THE BENEFITS FROM IMPLANT SURGERY MAY NOT MEET THE PATIENT'S EXPECTATIONS OR MAY DETERIORATE OVER TIME, REQUIRING REVISION SURGERY TO REPLACE THE IMPLANT OR TO CARRY OUT ALTERNATIVE PROCEDURES." USEFUL INFORMATION IS VERY LIMITED AT THIS TIME, AS THE FACILITY HAS YET TO PROVIDE ANY DETAILS ABOUT THE CASE ASIDE FROM THE PATIENT EXPERIENCING PAIN LEADING UP TO THE REMOVAL OF THE DEVICE, WHICH HAS NOT BEEN MADE AVAILABLE FOR RETURN AND WAS LIKELY DISCARDED.