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 2020-03-06 for ACTIS COLLARED HIGH SIZE 10 1010-12-100 101012100 manufactured by Depuy Ireland - 9616671.
[184547875]
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
[184547876]
The surgeon stated that the patient complained of pain. Radiolucent lines were present around the femoral stem in x-ray. The surgeon believed that the stem was loose and planned to revise if symptoms persist. Doi: (b)(6) 2019. Dor: not yet revised. Affected side: unknown.
Patient Sequence No: 1, Text Type: D, B5
[188143675]
Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary. 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 | 1818910-2020-07129 |
| MDR Report Key | 9801801 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2017-08-30 |
| Date Added to Maude | 2020-03-06 |
| 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 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| 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 HIGH SIZE 10 |
| Generic Name | HIP FEMORAL STEM |
| Product Code | KWL |
| Date Received | 2020-03-06 |
| Model Number | 1010-12-100 |
| Catalog Number | 101012100 |
| Lot Number | HF8315 |
| 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 | 2020-03-06 |