MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for HEMICAP FEMORAL CONDYLE ARTHROPLASTY manufactured by Arthrosurface, Inc..
[83501435]
Arthrosurface has limited information regarding this case from the source document received. The device was not returned for investigation. As no part number or lot number were provided, the manufacturing history of the implant device(s) installed in the patient could not be reviewed. There was no indication on the source document, whether only one implant device was loose or both the implant devices were loose at the time of the revision surgery. A cause for loosening of the device(s) under question cannot be ascertained due to availability of limited information. Should arthrosurface receive additional information regarding this case, a supplemental mdr will be submitted accordingly. Note that this report is for hemicap knee 20mm implant device, which is one of the 2 arthrosurface devices that were revised in the patient. The report pertaining to other implant device (hemicap pfxl) is # 3004154314-2017-00013.
Patient Sequence No: 1, Text Type: N, H10
[83501436]
Arthrosurface was notified of the information that a patient implanted with arthrosurface hemicap pfxl and knee devices was revised due to device loosening. This report is specific to the hemicap knee implant device which is not cleared by fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00014 |
| MDR Report Key | 6810724 |
| Date Received | 2017-08-22 |
| Date of Report | 2018-02-08 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2018-02-08 |
| 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 FEMORAL CONDYLE ARTHROPLASTY |
| Generic Name | KNEE JOINT FEMORAL (HEMI-KNEE) METALLIC UNCEMENTED PROSTHESIS |
| Product Code | KRR |
| Date Received | 2017-08-22 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-08-22 |