MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-18 for ACETABULAR CUP HAP SIZE 48/54 74122154 manufactured by Smith & Nephew Orthopaedics Ltd.
[179719809]
It was reported that in 2009 bhr components were implanted. Since 2018 elevated ion levels in whole blood were reported. In 2019 cobalt 3. 2 mcg/l in blood and cobalt 17. 6 mcg/l in urine. Mri in 2018 and (b)(6) 2019 shows cystic pseudotumor about 6 cm in diameter. In 2020 cobalt 1. 4 mcg/l in whole blood and urine cobalt was 14. 6 mcg/l.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975929-2020-00061 |
| MDR Report Key | 9719897 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-09 |
| Date Added to Maude | 2020-02-18 |
| 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 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 | ACETABULAR CUP HAP SIZE 48/54 |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
| Product Code | NXT |
| Date Received | 2020-02-18 |
| Catalog Number | 74122154 |
| Operator | LAY USER/PATIENT |
| 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. Required No Informationntervention | 2020-02-18 |