HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
Received Feb 26, 2021
Report 3004154314-2021-00001 · MDR key 11389433
Device
Generic name
Mtp Hemi-toe Prosthesis
Manufacturer
Arthrosurface, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Inadequate Pain Relief
- Inadequate Pain Relief
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE PATIENT, THE SURGEON RECOMMENDED STRETCHING THE TOE JOINT BUT THAT DID NOT HELP. THE REASON FOR PATIENT'S PAIN CANNOT BE ASCERTAINED DUE TO LACK OF INFORMATION REQUIRED FOR THE INVESTIGATION. SINCE NO DEVICE OR LOT INFORMATION IS UNAVAILABLE, A REVIEW OF DEVICE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. SEVERAL FACTORS SUCH AS STRESS/ PHYSICAL LOADS ON THE IMPLANTS, VASCULARITY OF THE IMPLANTATION SITE, SURGICAL TECHNIQUES EMPLOYED DURING IMPLANTATION, PATIENT FACTORS (SUCH AS AGE, PRE-EXISTING CONDITIONS, CURRENT STATE OF THE IMMUNE SYSTEM, BONE QUALITY, AND SENSITIVITY TO DEVICE MATERIALS), AND PATIENT POST-OP COMPLIANCE TO REHABILITATION PROCEDURES ETC. CAN HAVE IMPACT ON THE FUNCTIONAL EFFECTIVENESS OF THE IMPLANTED DEVICES. THE PATIENT WAS ADVISED TO CONSULT THEIR TREATING SURGEON FOR FURTHER EVALUATION OF THE REPORTED PAIN. THE COMPLAINT WILL BE CLOSED AT THIS TIME AND ANY NEW INFORMATION RECEIVED WILL BE REVIEWED AND REPORTED ACCORDINGLY.
Description of Event or Problem
PATIENT RECEIVED TOE HEMICAP IN (B)(6) 2020. CURRENTLY PATIENT IS EXPERIENCING SHARP PAIN AT THE BOTTOM OF THE TOE JOINT.
Remedial action
- Other