MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for DEPUY ASR XL FEM IMP SIZE 45 999890145 manufactured by Depuy International Ltd - 8010379.
[27898937]
Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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. The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive. Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions. Ref. (b)(4). Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[27898938]
Asr revision. Left. Xl. Reason(s) for revision: pain/ metallosis / high level of metal ions in the blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2015-32383 |
| MDR Report Key | 5138128 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-28 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2015-09-28 |
| Device Manufacturer Date | 2009-09-02 |
| Date Added to Maude | 2015-10-08 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| Manufacturer G1 | DEPUY INTERNATIONAL LTD - 8010379 |
| Manufacturer Street | ST. ANTHONY'S RD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1749/1816-2011 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEPUY ASR XL FEM IMP SIZE 45 |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | HSA |
| Date Received | 2015-10-08 |
| Catalog Number | 999890145 |
| Lot Number | 3015157 |
| Device Expiration Date | 2014-10-15 |
| 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 RD LEEDS LS118 DT UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-08 |