MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-19 for RF FSO CER ACET COMP 56MM 71332056 manufactured by Smith & Nephew, Inc..
[184142127]
It was reported that patient had a ho size 8 anthology stem put in with the old reflection ceramic system cup since 9 year ago. The patient had some pain over the last few months but then presented with acute pain. X-rays were taken and possibly bloods run and revision surgery was performed. The ceramic liner was broken and that was the reason for revision. When they opened up the liner was in 3-4 small pieces and the rest had disintegrated! There was a large amount of black fluid around all the prosthesis.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1020279-2020-00931 |
MDR Report Key | 9855874 |
Report Source | COMPANY REPRESENTATIVE,CONSUM |
Date Received | 2020-03-19 |
Date of Report | 2020-03-19 |
Date of Event | 2020-02-24 |
Date Mfgr Received | 2020-02-24 |
Date Added to Maude | 2020-03-19 |
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 Street | 1450 BROOKS ROAD |
Manufacturer G1 | SMITH & NEPHEW, INC. |
Manufacturer Street | 1450 BROOKS ROAD |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal Code | 38116 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RF FSO CER ACET COMP 56MM |
Generic Name | PRSTHSS, HP, SMI-CNSTRIND, UNCMNTED, MTL/PLYMR,PROS |
Product Code | MBL |
Date Received | 2020-03-19 |
Model Number | 71332056 |
Catalog Number | 71332056 |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SMITH & NEPHEW, INC. |
Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-19 |