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 2020-03-31 for SROM 9/10 16X11X130 30+4 900550210 manufactured by Depuy International Ltd - 8010379.
[186794912]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device is not distributed in the united states, but is similar to device marketed in the usa. The device reported is similar to fda product code: jdi.
Patient Sequence No: 1, Text Type: N, H10
[186794913]
The primary surgery was performed on (b)(6) 2010 via tha. It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the head (p/n: 152190062), the stem (p/n: 900550210) and the liner (liner and cup were manufactured by stryker) due to osteolysis of the femur, loosening of the stem, suspected armd. As an intraoperative pathological examination, there was no infection, nor no wear of the liner, however it was confirmed that there was wear debris at the head-neck junction. Osferion (artificial bone) was used for bone defect at the femur and medial greater trochanter. The surgery was completed without a surgical delay. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09791 |
| MDR Report Key | 9907655 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-31 |
| 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 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SROM 9/10 16X11X130 30+4 |
| Generic Name | S-ROM HIP SYSTEM : HIP FEMORAL STEM |
| Product Code | JDI |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-23 |
| Catalog Number | 900550210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-31 |