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 DEPUY ASR XL FEM IMP SIZE 49 999890149 manufactured by Depuy International Ltd - 8010379.
[186115529]
(b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. 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
[186115530]
Disclocation of acetabular implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09748 |
| MDR Report Key | 9904200 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2012-01-06 |
| 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 INT'L LTD. 8010379 |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1749/1816-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPUY ASR XL FEM IMP SIZE 49 |
| Generic Name | ASR HIP SYSTEM : HIP METAL FEMORAL HEADS |
| Product Code | KWA |
| Date Received | 2020-03-31 |
| Catalog Number | 999890149 |
| Lot Number | 2646680 |
| 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 | 2020-03-31 |