MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-03-14 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics, Inc.1818910.
[18625403]
Patient was revised to address infection.
Patient Sequence No: 1, Text Type: D, B5
[18765120]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. 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
[26434842]
(b)(4). The devices associated with this report were not returned. A complaint database search finds no other related incidents against the known product/lot combination(s) since release for distribution. A dhr review or lot specific database search was not possible for the additional product associated with this report as lot code(s) was not provided. Follow-up for additional event information was conducted utilizing work instruction wi-7915 appendix a. No additional information was obtained. The investigation could not draw any conclusions regarding the reported event. Based on the inability to determine a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2014-14427 |
| MDR Report Key | 3680255 |
| Report Source | 08 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-02-21 |
| Date of Event | 2014-02-21 |
| Date Mfgr Received | 2014-06-16 |
| Date Added to Maude | 2014-03-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STACEY TRICK |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714554 |
| 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 OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2014-03-14 |
| Catalog Number | 137621000 |
| Lot Number | UNKNOWN |
| 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.1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-14 |