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 2020-03-04 for ACTIS COLLARED STD SIZE 5 1010-11-050 101011050 manufactured by Depuy Ireland - 9616671.
[182153467]
(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
[182153468]
The patient was revised to address femur fracture and loosening of the stem at the bone to implant interface. Patient received a tha last week and fractured femur post operatively. Surgeon removed primary hip stem and head, then replaced both of those components with a competitors modular stem and head, leaving the original acetabular shell, screw, and liner in place. Doi: (b)(6) 2020; dor: (b)(6) 2020; right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-06845 |
| MDR Report Key | 9787975 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-10-21 |
| Date Added to Maude | 2020-03-04 |
| 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 | 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 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIS COLLARED STD SIZE 5 |
| Generic Name | HIP FEMORAL STEM |
| Product Code | KWL |
| Date Received | 2020-03-04 |
| Model Number | 1010-11-050 |
| Catalog Number | 101011050 |
| Lot Number | J5041H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |