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 2018-10-11 for CEMENTRALIZER 10.5 137638000 manufactured by Depuy Ireland - 9616671.
[123450270]
Product complaint # (b)(4). Investigation summary: 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
[123450271]
Sterile package not sealed.
Patient Sequence No: 1, Text Type: D, B5
[131389302]
Product complaint # :(b)(4). Investigation summary : 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, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-72265 |
| MDR Report Key | 7958242 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-04 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-10-11 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 10.5 |
| Generic Name | HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG |
| Product Code | LTO |
| Date Received | 2018-10-11 |
| Returned To Mfg | 2017-11-09 |
| Catalog Number | 137638000 |
| Lot Number | H19144 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-11 |