MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-23 for ELITE MODULAR HD 22.225MM +0 9625-67-000 962567000 manufactured by Depuy International Ltd - 8010379.
[186168595]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[186168596]
The primary surgery was performed in 2002 (the date was unknown) via tha. It was reported that the revision surgery (the date was unknown) was performed by replacing the c-stem (p/n: unknown) and the cup (p/n: unknown) due to the subluxation which the patient had 3 months before the revision surgery. The revision surgery was completed successfully, and it was unknown whether there was surgical delay or not. The condition after surgery was good. The surgeon found that there was something like a corrosion from the middle point to distal part of the explanted stem. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1818910-2020-08909 |
MDR Report Key | 9867986 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-03-23 |
Date of Report | 2020-03-05 |
Date Mfgr Received | 2020-03-05 |
Date Added to Maude | 2020-03-23 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | KARA DITTY-BOVARD |
Manufacturer Street | 700 ORTHOPAEDIC DR. |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal | 465810988 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | LEEDS MFG & MATERIAL WAREHOUSE |
Manufacturer Street | ST ANTHONYS ROAD |
Manufacturer City | LEEDS LS118DT |
Manufacturer Country | UK |
Manufacturer Postal Code | LS11 8DT |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ELITE MODULAR HD 22.225MM +0 |
Generic Name | SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS |
Product Code | KWY |
Date Received | 2020-03-23 |
Model Number | 9625-67-000 |
Catalog Number | 962567000 |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DEPUY INTERNATIONAL LTD - 8010379 |
Manufacturer Address | ST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-23 |