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 2017-11-13 for JOURNEY PFJ IMPLANT SM LT 71461012 manufactured by Smith & Nephew, Inc..
[91776475]
Patient Sequence No: 1, Text Type: N, H10
[91776476]
It was reported that patient underwent revision surgery for unspecified reasons. Knee converted to total knee.
Patient Sequence No: 1, Text Type: D, B5
[107771434]
[(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[107865209]
Corrections based on new information received.
Patient Sequence No: 1, Text Type: N, H10
[107865210]
It was additionaly reported that the component was in an optimal position according to the surgeon. The reson for revision surgery was progressive oa leading to medial compartment oa of the knee and surgeon chose to perform a total knee replacement due to the patient? S age.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2017-01006 |
| MDR Report Key | 7023916 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-13 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2010-03-18 |
| Date Added to Maude | 2017-11-13 |
| 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 | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 05001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 05001 |
| 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 | 3 |
| Brand Name | JOURNEY PFJ IMPLANT SM LT |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | KRR |
| Date Received | 2017-11-13 |
| Catalog Number | 71461012 |
| Lot Number | 10CM11723 |
| Operator | HEALTH PROFESSIONAL |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-11-13 |