MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2015-03-02 for CEMENTRALIZER 11.0 137620000 manufactured by Depuy Cmw 9610921.
[5461225]
Patient was revised to address possible infection.
Patient Sequence No: 1, Text Type: D, B5
[13001771]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26146734]
The complaint states patient was revised to address possible infection. A complaints database search and review of manufacturing records did not identify any anomalies. No device associated with this report was received for examination. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. Corrective action was not indicated. The complaint shall be closed with an undetermined conclusion it will be entered into the complaint database and monitored through trend analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-14943 |
| MDR Report Key | 4560103 |
| Report Source | 05,08 |
| Date Received | 2015-03-02 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-02-09 |
| Date Mfgr Received | 2015-03-27 |
| Device Manufacturer Date | 2014-08-26 |
| Date Added to Maude | 2015-03-02 |
| 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 | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| Manufacturer G1 | DEPUY CMW 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL, LANCASHIRE FY44QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 11.0 |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2015-03-02 |
| Catalog Number | 137620000 |
| Lot Number | 564483 |
| Device Expiration Date | 2019-07-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY CMW 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL, LANCASHIRE FY44QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-02 |