MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-24 for R3 44MM ID US COCR LNR 56MM 71341156 manufactured by Smith & Nephew Orthopaedics Ltd.
[186099849]
It was reported that the patient underwent a revision surgery of the left hip due to metallosis, pseudotumor, metal-stained tissue, and brown staining of tissue as the result of premature failure of the device. The r3 cocr liner and the cocr modular femoral head were explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975929-2020-00092 |
| MDR Report Key | 9875667 |
| Report Source | OTHER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-09-03 |
| Date Mfgr Received | 2020-03-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS LTD |
| Manufacturer Street | AURORA HOUSE SPA PARK |
| Manufacturer City | LEAMINGTON SPA CV313HL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CV31 3HL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R3 44MM ID US COCR LNR 56MM |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
| Product Code | NXT |
| Date Received | 2020-03-24 |
| Catalog Number | 71341156 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS LTD |
| Manufacturer Address | AURORA HOUSE SPA PARK LEAMINGTON SPA CV313HL UK CV31 3HL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-24 |