MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for 12/14 ARTICUL 40MM TRIAL +12 2531-08-000 253108000 manufactured by Depuy Orthopaedics Inc Us.
[186175472]
Product complaint # (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
[186175473]
It was reported that the 32 + 40mm head trials need replaced due to scratches.
Patient Sequence No: 1, Text Type: D, B5
[188144005]
Product complaint #: (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. Depuy-synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary. Examination of the returned instrument confirmed the complaint of scratching. Based on the investigation, the need for corrective action is not indicated. 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
| Report Number | 1818910-2020-09663 |
| MDR Report Key | 9901026 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2006-02-15 |
| Date Added to Maude | 2020-03-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| 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 | 12/14 ARTICUL 40MM TRIAL +12 |
| Generic Name | HIP INSTRUMENTS : FEMORAL TRIALS |
| Product Code | LXH |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-23 |
| Model Number | 2531-08-000 |
| Catalog Number | 253108000 |
| Lot Number | DPG0206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-30 |