MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-03-24 for ACETABLR CUP HAP 44MM W/ IMPTR 74120144 manufactured by Smith & Nephew Orthopaedics Ltd.
[186094963]
It was reported that a revision surgery on the right hip was performed due to pain, failure of hardware, elevated levels of cobalt and chromium, metal toxicity, metallosis, pseudotumors, bone and tissue loss, and loss of mobility. The patient was previously implanted with a bhr resurfacing system. There is no information regarding to the devices explanted on the revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975929-2020-00091 |
| MDR Report Key | 9875606 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-27 |
| 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 | ACETABLR CUP HAP 44MM W/ IMPTR |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
| Product Code | NXT |
| Date Received | 2020-03-24 |
| Model Number | 74120144 |
| Catalog Number | 74120144 |
| 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 |