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 2020-03-24 for PFC SIGMARP CV TB/IN S3 15.0 96-2033 962033 manufactured by Depuy Orthopaedics Inc Us.
[188404132]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188404133]
Left knee revision; surgeon: (b)(6), primary implant date: (b)(6) 2008. Reason for revision: patient fell 12 months ago, instability noted since this incident. This is the patient's first revision. Good outcome post surgery; no adverse effect on patient. Female patient (b)(6), dob: (b)(6) years old, (b)(6) kgs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09125 |
| MDR Report Key | 9874359 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-08 |
| Device Manufacturer Date | 2007-07-17 |
| Date Added to Maude | 2020-03-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY IRELAND 9616671 |
| Manufacturer Street | LOUGHBEG, RINGASKIDDY CO. |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFC SIGMARP CV TB/IN S3 15.0 |
| Generic Name | SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT |
| Product Code | NJL |
| Date Received | 2020-03-24 |
| Model Number | 96-2033 |
| Catalog Number | 962033 |
| Lot Number | 2423889 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |