MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-24 for HEMICAP - PATELLO-FEMORAL RESURFACING PROSTHESIS P306-0090-W manufactured by Arthrosurface, Inc..
[70764255]
As soon as the complaint was received, it was forwarded to the european distributor to follow-up with the patient. The distributor did not receive any response from the patient after advising to consult the doctor regarding her issues. Arthrosurface is regularly following-up with the distributor for new information regarding issues from the patient or the treating physician. The manufacturing records (package and the component levels) of the metal and uhmwpe components were reviewed. All parts manufactured, inspected and packaged per specifications. There are no issues relative to the patient's complaint. The surgical history of component lots in question (hemicap and the uhmwpe patella) was reviewed and no complaints have been received as of date of this report. The reasons for the pain cannot be concluded with the information available at this time. However, various aspects such as patient factors, surgical/ operating technique, compliance to post-operative rehabilitation technique etc contribute to the outcome of the surgery and functionality of the implants. The patella component in question was not returned and hence the device evaluation could not be performed. Should arthrosurface receive any new or additional information regarding this complaint, a supplemental mdr will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[70764256]
The complainant is a european patient who reached out to arthrosurface via website. The patient received arthrosurface patello-femoral xl resurfacing implants in (b)(6) 2015 and did not get pain relief as expected. She states that her uhmwpe patella cap was worn out within 18 months of implantation and was informed that the device's life expectancy is at least 15 years. She is concerned the implant material is a mistake.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00003 |
| MDR Report Key | 6431203 |
| Report Source | CONSUMER |
| Date Received | 2017-03-24 |
| Date of Report | 2017-02-25 |
| Date Mfgr Received | 2017-02-25 |
| Device Manufacturer Date | 2013-11-27 |
| Date Added to Maude | 2017-03-24 |
| 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 | PATIENT |
| 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 | 3 |
| Brand Name | HEMICAP - PATELLO-FEMORAL RESURFACING PROSTHESIS |
| Generic Name | KNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS |
| Product Code | KRR |
| Date Received | 2017-03-24 |
| Model Number | P306-0090-W |
| Catalog Number | P306-0090-W |
| Lot Number | 75KC0805 |
| Device Expiration Date | 2018-11-30 |
| 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 | 2017-03-24 |