MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-03 for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS PX02-0218 / PX02-0705-W manufactured by Arthrosurface, Inc..
[59123543]
The exact reason for the metallosis is not known. According to arthrosurface engineering, the inner surface of the pfxl articular implant taper showed no signs of metal wear. However, wear/damage was noticed on the outer surface of the ti fixation components. From radiographs obtained, it cannot be confirmed, but it appears that the tapers were not seated properly, possibly from the initial implantation. As such, this may have caused rocking movement leading to the friction between both components. Review of the complaint history indicated no prior complaints for the part-lot combinations associated with the reported devices. Review of device history records (dhrs) identified no manufacturing deviations that would have caused or contributed to the reported issue. All arthrosurface hemicap implants undergo wear, corrosion and fretting tests as a part of their design and developmental stages. No occurences of material disintegration or decomposition have been reported in any arthrosurface hemicap implant history. Based on the information available, no further conclusions can be drawn. The complaint is considered closed at this time. Manufacturing and expiry dates of the implants under question are specified below part # px02-0705-w, lot # 75hb3020, mfg. Date: 08-2012, exp. Date: 08-2019. Part # px11-0218-w, lot # 75hb2020, mfg. Date: 08-2012, exp. Date: 08-2017.
Patient Sequence No: 1, Text Type: N, H10
[59123544]
Patient has arthrosurface pfxl hemicap implanted ((b)(6) 2012) in conjunction with stryker's ukr implant. The implantation date of stryker components is not known. The patient presented with pain in his left knee to the clinic after 2 weeks of arthroscopy and complains that he doesn't get pain relief as expected. Surgical findings revealed advanced arthritic disease in the lateral compartment. In his report dated (b)(6) 2016, the surgeon suspects that a titanium reaction leading to metallosis is caused at the trunnion where the two arthrosurface pfxl components join. The surgeon states that there were no signs of surface wear or damage or loosening of either of the implants. However, the implant was loose at the time of revision ((b)(6) 2016).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2016-00014 |
| MDR Report Key | 6078003 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2016-10-04 |
| Date Added to Maude | 2016-11-03 |
| 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 | 3 |
| Brand Name | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS |
| Generic Name | KNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS |
| Product Code | KRR |
| Date Received | 2016-11-03 |
| Returned To Mfg | 2016-10-18 |
| Model Number | PX02-0218 / PX02-0705-W |
| Lot Number | 75HB2020 / 75HB3020 |
| 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 | 1. Other | 2016-11-03 |