MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-19 for DURALOC CONST LINER 50X28 1241-10-527 124110527 manufactured by Depuy Orthopaedics Inc Us.
[188067724]
(b)(4). Initial reporter occupation: lawyer. 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
[188067725]
After review of medical records, it was stated that the patient underwent irrigation and debridement to address infection. Operative notes reported serous fluid draining but not purulent. Doi: (b)(6) 2009; doe: (b)(6) 2009; right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-05371 |
| MDR Report Key | 9729463 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-05 |
| Date of Event | 2009-09-14 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2005-08-12 |
| Date Added to Maude | 2020-02-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| 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 | DURALOC CONST LINER 50X28 |
| Generic Name | DURALOC IMPLANT : HIP POLY ACETABULAR LINERS |
| Product Code | KWZ |
| Date Received | 2020-02-19 |
| Model Number | 1241-10-527 |
| Catalog Number | 124110527 |
| Lot Number | Z2TKL1000 |
| Device Expiration Date | 2010-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |