MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-31 for DLT TS CER HD 12/14 40MM +5.0 1365-40-720 136540720 manufactured by Depuy Orthopaedics Inc Us.
[186812004]
(b)(4). Initial reporter occupation: lawyer. (b)(4). 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
[186812005]
Pcf and medical records received. After review of medical records patient was revised to addressed left infected total hip arthroplasty operative notes indicated scarring and small posterior superior defect. Pathology reprot reported of patchy acute and chronic inflammation. Doi: (b)(6) 2010 (cup, stem); doi: (b)(6) 2016 (liner & head); dor: (b)(6) 2017 left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09726 |
| MDR Report Key | 9903554 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-13 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2016-08-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY IRELAND 9616671 |
| Manufacturer Street | LOUGHBEG, RINGASKIDDY CO. |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DLT TS CER HD 12/14 40MM +5.0 |
| Generic Name | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS |
| Product Code | LZO |
| Date Received | 2020-03-31 |
| Model Number | 1365-40-720 |
| Catalog Number | 136540720 |
| Lot Number | 8374043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-31 |