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..
[83519352]
Arthrosurface has limited information regarding this case from the source document received. Since the device was not received for evaluation, reported wear on the device (patella chunk) could not be confirmed. As no part number and lot number were provided, the manufacturing history of the implant device(s) installed in the patient could not be reviewed. The reasons for worn patella or pain could not be ascertained due to limited information. 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
[83519353]
Arthrosurface was notified of the information that a patient implanted with hemicap pfxl implant was revised due to pain. The surgeon noted a patella chunk at the time of revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00012 |
| MDR Report Key | 6810713 |
| Date Received | 2017-08-22 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-05-12 |
| 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 |