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 2020-02-11 for ACTIS COLLARED STD SIZE 5 101011050 manufactured by Depuy Ireland - 9616671.
[188513377]
(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
[188513378]
This medical device complaint addresses a right total hip revision on (b)(6) 2019, for treatment of deep infection. This revision was the stage one procedure, of a two stage procedure to address infection, with explantation of all products and placement of an antibiotic spacer. The event concluded on (b)(6) 2020 with the second stage re-implantation procedure following resolution of all infection. The primary hip was originally implanted on (b)(6) 2019. Due to the relatively short period of time between implantation and the onset of infection, it cannot be ruled-out that the implantation products or procedure may have caused or contributed to the infection event. The clinical database indicates that the devices explanted on (b)(6) 2019 were depuy products, but no device logs are available containing product and lot code information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-04492 |
| MDR Report Key | 9693965 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-10-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-04-10 |
| Date Added to Maude | 2020-02-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | LOUGHBEG RINGASKIDDY CO. |
| Manufacturer City | CORK IN |
| Manufacturer Country | EI |
| 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 | ACTIS COLLARED STD SIZE 5 |
| Generic Name | HIP FEMORAL STEM |
| Product Code | KWL |
| Date Received | 2020-02-11 |
| Catalog Number | 101011050 |
| Lot Number | J27H02 |
| 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 IN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |