MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-10-01 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics, Inc..
[1473228]
Pt revised for pain, osteolysis and polyethylene wear.
Patient Sequence No: 1, Text Type: D, B5
[8711291]
The products associated with this reported event were not returned. A search of the complaint database did not show any other reports against the provided product/lot code combinations. The investigation could not draw any conclusions about the reported event with the provided info. No evidence was found suggesting product error was a contributing factor and the need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should the product and/or additional info 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 | 1818910-2010-06757 |
| MDR Report Key | 1858381 |
| Report Source | 05,08 |
| Date Received | 2010-10-01 |
| Date of Report | 2010-09-07 |
| Date of Event | 2010-09-07 |
| Date Mfgr Received | 2010-09-07 |
| Device Manufacturer Date | 2001-02-06 |
| Date Added to Maude | 2010-10-08 |
| 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 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 12.0 |
| Generic Name | 87 LTO |
| Product Code | LTO |
| Date Received | 2010-10-01 |
| Model Number | NA |
| Catalog Number | 137621000 |
| Lot Number | U5HB81020 |
| 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 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-01 |