HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
Received Jul 3, 2019
Report 3004154314-2019-00005 · MDR key 8760100
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
ON FOLLOWING-UP, THE PATIENT STATED THAT SHE DID NOT GET X-RAYS TO SEE IF THE ARTHRITIS PROGRESSED. SHE ALSO STATED THAT BOTH THE SURGEONS FELT THAT HER SEASMOIDS WERE EFFECTED WHICH COULD BE THE REASON FOR THE REPORTED PAIN. THE EXACT CAUSE FOR REPORTED PAIN AND DIMINISHED MOBILITY IS UNKNOWN. THE PART AND LOT INFORMATION OF THE DEVICE IN QUESTION ARE UNKNOWN. HENCE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE CONDUCTED. THE PACKAGE INSERT OF THE DEVICE STATES THAT THIS TYPE OF EVENT(S) CAN OCCUR AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. AN APPROPRIATE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENTS WAS NOT PROVIDED. SHOULD ARTHROSURFACE RECEIVE ANY ADDITIONAL INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MDR WILL BE FILED ACCORDINGLY.
Description of Event or Problem
THE PATIENT REACHED OUT TO ARTHROSURFACE VIA SOCIAL MEDIA AND STATED SHE RECEIVED THE TOE HEMICAP 2 YEARS AGO AND SINCE HAS BEEN IN PAIN. ACCORDING TO HER, THE ORIGINAL SURGEON AND SECOND OPINION SURGEON HAD SUGGESTED USING ORTHOTICS FOR PAIN RELIEF. ORTHOTICS HELPED BUT SHE IS STILL EXPERIENCING PAIN.