MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS manufactured by Arthrosurface, Inc..
[83501350]
The surgeon noted that the reason for revision was progression of disease, which may have contributed to the pain reported by the patient. Since the implant device was not returned for evaluation, wear reported on the device (uhmwpe patellar component) could not be confirmed. Due to inadequate information in the source document received, conclusions cannot be drawn on the cause for reported wear. As no part number or lot number were provided, the manufacturing history of the implant device(s) removed from the patient could not be reviewed. Additional information pertaining to devices removed from the patient was requested. If additional information becomes available, a supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[83501351]
Arthrosurface was notified of the information that a patient implanted with arthrosurface hemicap pfxl device was revised due to pain. The surgeon also noted wear on the patellar component at the time of the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00015 |
| MDR Report Key | 6810748 |
| Date Received | 2017-08-22 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS |
| Generic Name | KNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS |
| Product Code | KRR |
| Date Received | 2017-08-22 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-22 |