MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-12-03 for CEMENTRALIZER 15.0 137637000 manufactured by Depuy Orthopaedics, Inc..
[17064643]
During the surgery the cementralizer stuck in the canal, surgeon was unable to fully seat the stem and could not remove it. Cement had to be removed and a bone fracture occurred during removal.
Patient Sequence No: 1, Text Type: D, B5
[17242926]
The device associated with this report was not returned. A complaint database search finds no other reported incidents against the provided product and lot code since its release for distribution. The investigation could not draw any conclusions regarding the reported event. Based on the investigation, the need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should the product and/or additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2009-06966 |
| MDR Report Key | 1552408 |
| Report Source | 05,07 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-11-07 |
| Date of Event | 2009-11-07 |
| Date Mfgr Received | 2009-11-07 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2009-12-10 |
| 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 | KATHERINE SEPPA, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 15.0 |
| Generic Name | 87LTO |
| Product Code | LTO |
| Date Received | 2009-12-03 |
| Model Number | NA |
| Catalog Number | 137637000 |
| Lot Number | DH8MN1000 |
| ID Number | NA |
| 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. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46581098 US 46581 0988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-03 |