MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-18 for ACETABLR CUP manufactured by Smith & Nephew Orthopaedics Ltd.
[179737465]
In 2011 patient had bhr surgery, and is having pain since 2017. In 2019 pt had a stroke, and since then the pt does not feel any sensation in the hip, however, pt has considerable and constant pain in right side from head to toes. In addition, the patient has reported chest pain with occasional arrhythmias, inability to urinate, regular tingling sensation, metallic taste, backache above right hip, sensitive and mood swings. The hip was revised in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975929-2020-00063 |
| MDR Report Key | 9720159 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 1901-01-01 |
| Date Mfgr Received | 2020-02-12 |
| 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 | ACETABLR CUP |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
| Product Code | NXT |
| Date Received | 2020-02-18 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-18 |