MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-30 for PRO CONF PL TB ISRT RT S2 10 71508121 manufactured by Smith & Nephew, Inc..
[112840054]
Patient Sequence No: 1, Text Type: N, H10
[112840055]
I was informed by dr (b)(6) to provide implants for the above case. Requested profix inserts. Intra-operatively we realized that the implants insitu was not a profix knee and was an advantum knee instead due to the profix insert not fitting properly. I advised the surgeon that this was the case but due to surgery in progress, he decided to still use the profix insert as the advantum one wasn't available. I advised the surgeon that the articulation will be affected and this was acknowledged.
Patient Sequence No: 1, Text Type: D, B5
[125022781]
The associated complaint device was not returned for evaluation. A clinical evaluation noted that several attempts have been made to obtain clinical/medical documents to no avail. Without supporting clinical/medical documents a thorough investigation cannot be performed. Should information become available this complaint can be re-assessed. Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes. A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number. Without the return of the actual product involved, our investigation of this report is inconclusive. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. We consider this investigation closed. Should additional information be received, the complaint will be reopened. Credit cannot be issued for this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2018-01251 |
| MDR Report Key | 7653906 |
| Date Received | 2018-06-30 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-06-14 |
| Date Mfgr Received | 2018-06-14 |
| Date Added to Maude | 2018-06-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRO CONF PL TB ISRT RT S2 10 |
| Generic Name | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2018-06-30 |
| Catalog Number | 71508121 |
| Lot Number | 10LM03501 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 2018-06-30 |