MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-02-12 for BHR ACETABULAR CUP 60MM 74120160 manufactured by Smith & Nephew Orthopaedics Ltd.
[178744762]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178744763]
It was reported that right hip revision surgery was performed due to pain, metallosis, memory loss and leg length discrepancy.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005975929-2020-00050 |
MDR Report Key | 9699216 |
Report Source | CONSUMER,FOREIGN,OTHER |
Date Received | 2020-02-12 |
Date of Report | 2020-02-12 |
Date of Event | 2015-04-21 |
Date Mfgr Received | 2019-11-01 |
Device Manufacturer Date | 2009-03-05 |
Date Added to Maude | 2020-02-12 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 0 |
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 | BHR ACETABULAR CUP 60MM |
Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
Product Code | NXT |
Date Received | 2020-02-12 |
Catalog Number | 74120160 |
Lot Number | 098133 |
Device Expiration Date | 2014-02-28 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
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 | 2020-02-12 |