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 C-STEM SZ2 9611-62-000 961162000 manufactured by Depuy International Ltd - 8010379.
[188860732]
(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
[188860733]
The primary surgery was performed on (b)(6) 2004 via tha. It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the c-stem (p/n: unknown) and the cup (p/n: unknown) due to a pain which the patient had left and right side of his hip joints at the same time in autumn 2019 (the date was unknown). 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. He thought that this caused the pain. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08910 |
| MDR Report Key | 9868038 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-10 |
| 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 | C-STEM SZ2 |
| Generic Name | C-STEM HIP IMPLANT : HIP FEMORAL STEM |
| Product Code | KXA |
| Date Received | 2020-03-23 |
| Model Number | 9611-62-000 |
| Catalog Number | 961162000 |
| 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 |