MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-12-05 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics Inc Us.
[129322817]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129322818]
Clinical adverse event received for foot drop.
Patient Sequence No: 1, Text Type: D, B5
[132382823]
Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. 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. Update 21-dec-2018: investigation re-opened upon receipt of additional information. The new information does not affect the previous investigation. 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 | 1818910-2018-77222 |
| MDR Report Key | 8132959 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-12-05 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2019-01-02 |
| Device Manufacturer Date | 2018-08-24 |
| Date Added to Maude | 2018-12-05 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER IN 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 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 12.0 |
| Generic Name | HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG |
| Product Code | LTO |
| Date Received | 2018-12-05 |
| Catalog Number | 137621000 |
| Lot Number | J04N00 |
| 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. Other | 2018-12-05 |