MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-18 for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS PX11-0218-W/ P255-1050-W/ PX02-1004-W manufactured by Arthrosurface, Inc..
[83028271]
Arthrosurface vp - clinical affairs, has reviewed the information and recommended the patient to consult a medical professional to discuss her knee issues. As a part of investigation, the manufacturing history of lots of articular, taper post and patellar components implanted in the patient was reviewed. No issues found and noted that all parts were properly inspected and discrepant parts were sorted out accordingly. Also, a review was conducted on number of surgeries/ cases recorded where the above lots were used individually and in combination. No complaints were recorded to date with these implant components. The cause of reported knee pain cannot be concluded as there are several factors that influence outcome of a surgery such as patient factors, surgical/ operating technique, compliance to post-operative rehabilitation technique etc. Arthrosurface is currently assisting the patient to find a surgeon in her area for obtaining a second opinion. Any additional reportable information will be filed accordingly through supplemental mdrs. Following is the information related to implant components installed in the patient: part # p255-1050-w lot # 75dc2443 mfg. Dt: 2013-05 exp. Dt: 2018-05. Part # px02-1004-w lot # 75be0528-2x mfg. Dt: 2015-02 exp. Dt: 2012-02. Part # px11-0218-w lot # 75ef0623-r mfg. Dt: 2016-05-25 exp. Dt: 2021-05-25.
Patient Sequence No: 1, Text Type: N, H10
[83028272]
The patient reached out to arthrosurface via website to report pain in her knee. According to the patient, her operating surgeon told that she could return to normal activities within 3-6 months of surgery. But, it has been 6 months since she received a pf implant and there is no pain relief to date. Patient also complains she is not as mobile as before and has become very limited on her activities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00010 |
| MDR Report Key | 6803574 |
| Report Source | CONSUMER |
| Date Received | 2017-08-18 |
| Date of Report | 2017-07-30 |
| Date Added to Maude | 2017-08-18 |
| 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 | 2017-08-18 |
| Model Number | PX11-0218-W/ P255-1050-W/ PX02-1004-W |
| 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 | 2017-08-18 |