MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for SIG RP AOX STB INS SZ3 12.5 1961-92-132 196192132 manufactured by Depuy Orthopaedics Inc Us.
[185895940]
Product complaint # (b)(4). Initial reporter occupation: lawyer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185895941]
After review of medical record dated (b)(6) 2020, it was reported that patient suffered from adhesion, pain, allergic reaction. Doi: (b)(6) 2018, dor: (b)(6) 2019, right knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09814 |
| MDR Report Key | 9908051 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2016-03-16 |
| Date Added to Maude | 2020-03-31 |
| 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 | 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 |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIG RP AOX STB INS SZ3 12.5 |
| Generic Name | SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT |
| Product Code | NJL |
| Date Received | 2020-03-31 |
| Model Number | 1961-92-132 |
| Catalog Number | 196192132 |
| Lot Number | 8263556 |
| 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 | 2020-03-31 |