MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-29 for PRO CONF PL TB ISRT RT S4 12 71508142 manufactured by Smith & Nephew Orthopaedics Ag.
[118610304]
Patient Sequence No: 1, Text Type: N, H10
[118610305]
It was reported that patient underwent primary right total knee replacement by dr (b)(6), (b)(6) 2005. Now presents to surgeon complaining of anterior knee pain. Revision surgery in (b)(6) 2018 involving insert exchange and patella resurfacing (patella not resurfaced at time of primary surgery).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613369-2018-00055 |
| MDR Report Key | 7827931 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-29 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-08-01 |
| Device Manufacturer Date | 2003-10-31 |
| Date Added to Maude | 2018-08-29 |
| 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 | OBERNEUHOFSTRASSE 10D |
| Manufacturer City | BAAR, 06340 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 06340 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU, CH5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH5000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO CONF PL TB ISRT RT S4 12 |
| Generic Name | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2018-08-29 |
| Catalog Number | 71508142 |
| Lot Number | 03KM07667 |
| Device Expiration Date | 2013-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Address | OBERNEUHOFSTRASSE 10D BAAR, 06340 SZ 06340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-08-29 |