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 manufactured by Arthrosurface, Inc..
[83012461]
The radiographs provided by the patient were reviewed by arthrosurface ceo and head of engineering and vp - clinical affairs who concluded that the taper post component is placed too deep in the bone which resulted in poor fixation of both the components. It is possible that the operating surgeon may not have used a taper depth gauge for placement of the screw. The patient is currently seeking opinion on further treatment options for which arthrosurface has responded to.
Patient Sequence No: 1, Text Type: N, H10
[83012462]
The patient reached out to arthrosurface via website to report pain in his left knee. He received a pfxl hemicap 1 year ago, and since has not received pain relief. Following an arthroscopy procedure recently, his surgeon removed scar/ inflammatory tissue in the knee which reduced inflammation but not pain. This information was forwarded to arthrosurface vp - clinical affairs, for review. The patient was advised to consult his treating surgeon or to obtain a second opinion regarding his on-going issues. The patient obtained second opinion from 2 other doctors and was told that his hemicap is loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00009 |
| MDR Report Key | 6803566 |
| Report Source | CONSUMER |
| Date Received | 2017-08-18 |
| Date of Report | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| 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 |
| 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 |