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 2019-05-13 for CEMENTRALIZER 9.25MM 137647000 manufactured by Depuy Orthopaedics Inc Us.
[144858989]
(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
[144858990]
The patient was revised to address infection and loosening at the cement to implant interface. There was also removal of implants, wash out and re-implantation. Doi: (b)(6) 2019; dor: (b)(6) 2019, left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-93300 |
| MDR Report Key | 8604796 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-13 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-05-31 |
| Device Manufacturer Date | 2019-02-28 |
| Date Added to Maude | 2019-05-13 |
| 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 | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| 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 | CEMENTRALIZER 9.25MM |
| Generic Name | HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG |
| Product Code | JDK |
| Date Received | 2019-05-13 |
| Catalog Number | 137647000 |
| Lot Number | J27P92 |
| 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 ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-13 |