MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for C-STEM SZ 2 HIGH OFFSET 9613-15-000 961315000 manufactured by Depuy International Ltd - 8010379.
[186173855]
(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
[186173856]
The primary surgery was performed on (b)(6) 2013 via tha. It was reported that there was an indication of infection for several years, and the surgeon had administered antibiotic to the patient and followed infection? S progress. However, on (b)(6) 2020, the removal surgery was performed. The surgeon removed the cup (p/n: 965328047), the head (p/n: 962734000), the c-stem (p/n: 961315000), the centralizer (p/n: 961246000), the end cap (p/n: 961226000) and the cement restrictor (p/n: 546014000) and placed a cement space molds. The surgery was completed, and it was unknown whether there was a surgical delay or not. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09648 |
| MDR Report Key | 9900791 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-15 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-15 |
| Device Manufacturer Date | 2012-08-07 |
| Date Added to Maude | 2020-03-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | JJMSZ PLANT FOR STK. & N-STK. |
| Manufacturer Street | NO. 299, CHANGYANG STREET SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU, JIANGSU 215126 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-STEM SZ 2 HIGH OFFSET |
| Generic Name | C-STEM HIP IMPLANT : HIP FEMORAL STEM |
| Product Code | JDI |
| Date Received | 2020-03-30 |
| Model Number | 9613-15-000 |
| Catalog Number | 961315000 |
| Lot Number | D12071970 |
| 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 | 2020-03-30 |