MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-21 for ACTIS COLLARED STD SIZE 6 1010-11-060 101011060 manufactured by Depuy Ireland - 9616671.
[188684559]
(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
[188684560]
The primary surgery was performed in 2019 via tha. It was reported that it was confirmed last month that sinking of the stem and loosening caused by aff, thus the removal surgery was performed by explanting the actis stem of the patient? S left hip joint. The surgery was completed, and it was unknown whether there was a surgical delay or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-05719 |
| MDR Report Key | 9741649 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2018-09-11 |
| Date Added to Maude | 2020-02-21 |
| 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 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 6 |
| Generic Name | HIP FEMORAL STEM |
| Product Code | KWL |
| Date Received | 2020-02-21 |
| Model Number | 1010-11-060 |
| Catalog Number | 101011060 |
| Lot Number | HZ6046 |
| 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 IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-21 |