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 2007-1510 manufactured by Arthrosurface, Inc..
[86313746]
The risk involved with seized broken pin tips is minimal as the guide pins are manufactured using implant grade (b)(4) stainless steel (per astm f138) material. Based on the investigation results, it appears that excessive force may have been used while extracting the pins from the guide block. The lot was manufactured to specifications; manufacturing records including material certificates, inspection records. , etc were reviewed and no issues were noted. The surgeon decided to leave the pieces in and completed the case with no other issues. Should arthrosurface receive any additional information regarding this case, the investigation will be re-opened and reported through a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
[86313747]
Two guide pins broke while preparing the pfxl hemicap implant site. The pins were seized in patient's bone and were not retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00018 |
| MDR Report Key | 6865173 |
| 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 | 2011-03-30 |
| 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 |
| Model Number | 2007-1510 |
| Lot Number | 75CK2423 |
| 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 | 2017-09-14 |