MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2006-08-09 for PRSVN MB TIB TRAY LM/RL CEM S4 149826004 manufactured by Depuy-raynham, A Div Of Depuy Orthopaedics, Inc..
[18576737]
The patient was revised due to loosening.
Patient Sequence No: 1, Text Type: D, B5
[18696474]
Evaluation was not possible, as the products were not returned. A search of the complaint database did not reveal any other reports for the reported product lot numbers. The initial reporting stated, the products are not suspected of failing to meet specifications or contributing to the event. The investigation could not verify or draw any conclusions about the root cause of the reported femoral and tibial component loosening. No evidence was found suggesting product contribution to the reported event and the need for corrective action is not indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2006-02463 |
| MDR Report Key | 747153 |
| Report Source | 05,08 |
| Date Received | 2006-08-09 |
| Date of Report | 2006-07-27 |
| Date of Event | 2006-07-27 |
| Date Facility Aware | 2006-07-27 |
| Report Date | 2006-07-27 |
| Date Mfgr Received | 2006-07-27 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2006-08-15 |
| 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 | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 0350 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRSVN MB TIB TRAY LM/RL CEM S4 |
| Generic Name | TOTAL KNEE PROSTHHESIS |
| Product Code | MBD |
| Date Received | 2006-08-09 |
| Model Number | NA |
| Catalog Number | 149826004 |
| Lot Number | YGF21 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 734936 |
| Manufacturer | DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 027670350 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-09 |