MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS PX75-0173 manufactured by Arthrosurface, Inc..
[86313591]
The surgeon was able to finish the case using a pfxl taper post component readily available with the rep. An additional technique step had to be performed to use the taper post as an alternative fixation component. Two guide pins were broken with their tips seized in patient's bone while preparing the implant site. There is no correlation between the fixation stud in question and the broken pins. Hence, a separate mdr (reference mdr# 3004154314-2017-00018) was filed to report the broken guide pins. The surgeon was happy with the final outcome of the case. The fixation stud in question was returned and the complaint was confirmed. Based on the investigation results, we believe that this is a 1-off incident that resulted due to an operator error. The operator is no longer with the contract manufacturing organization.
Patient Sequence No: 1, Text Type: N, H10
[86313592]
Arthrosurface was notified of a fixation stud that would not mate with its corresponding femoral articular component. The surgeon suspects that the stud in question may be lacking a taper feature which is essential for mechanical interlocking of articular and fixation components.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00017 |
| MDR Report Key | 6865147 |
| Date Received | 2017-09-14 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-06-06 |
| Date Mfgr Received | 2017-08-18 |
| Device Manufacturer Date | 2016-07-08 |
| Date Added to Maude | 2017-09-14 |
| 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 | 2017-09-14 |
| Returned To Mfg | 2017-08-25 |
| Model Number | PX75-0173 |
| Lot Number | 75GF0513-2XR |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-14 |