MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-12-18 for UNKNOWN DEPUY ASR FEMORAL HEAD UNK-ASR manufactured by Depuy Intl., Ltd. - 8010379.
[5200174]
Sales rep reported revision surgery. Patient has been revised at their request. No symptoms reported. X-rays appeared to represent well-fixated components. Update rec? D 08/11/2014 - legal claim was received, which identified dob information. There was no new information that would change the outcome of the investigation. The complaint was updated on: 09/09/2014. Update rec'd 11/26/2014- litigation papers received. Litigation alleges pain, discomfort, soreness, malaise, swelling, loss of energy, immobilization and both acute localized damage to tissue and/or bone surrounding the acetabulum and systemic injuries, and elevated metal ion levels. The stem and sleeve are being added. The existing mdr decision has been reversed and cup and head are being reported. The complaint was updated on: 12/18/2014.
Patient Sequence No: 1, Text Type: D, B5
[12675499]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: unavailable. This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2014-34717 |
| MDR Report Key | 4344200 |
| Report Source | 00 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-11-26 |
| Date of Event | 2014-02-17 |
| Date Mfgr Received | 2014-11-26 |
| Date Added to Maude | 2014-12-19 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 INTL., LTD. - 8010379 |
| Manufacturer Street | ST. ANTHONY'S RD |
| Manufacturer City | LEEDS LS118 D |
| 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 | UNKNOWN DEPUY ASR FEMORAL HEAD |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | KSA |
| Date Received | 2014-12-18 |
| Catalog Number | UNK-ASR |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY INTL., LTD. - 8010379 |
| Manufacturer Address | ST. ANTHONY'S RD LEEDS LS118 D UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-18 |