MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2007-01-02 for PRSVN MB TIB TRAY RM/LL CEM S3 149825003 manufactured by Depuy Orthopaedics, Depuy-cork.
[19255179]
Patient was revised to address pain in the knee.
Patient Sequence No: 1, Text Type: D, B5
[19515332]
Examination was not possible as no product was returned. The initial report states that there was nothing found wrong with the tibial component, the tray as well fixed and the poly intact. The investigation did not find any evidence of product contribution to the reported pain. The need for corrective action was not identified. Should additional info be rec'd, the complaint will be reopened. Depuy considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2006-04338 |
| MDR Report Key | 801147 |
| Report Source | 05,08 |
| Date Received | 2007-01-02 |
| Date of Report | 2006-12-12 |
| Date of Event | 2006-12-12 |
| Date Mfgr Received | 2006-12-12 |
| Date Added to Maude | 2007-01-09 |
| 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 | 0 |
| 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 |
| Manufacturer Street | LOUGHBEG |
| Manufacturer City | RINGASKIDDY CTY, CORK |
| Manufacturer Country | EI |
| 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 RM/LL CEM S3 |
| Generic Name | 87MBD |
| Product Code | MBD |
| Date Received | 2007-01-02 |
| Model Number | NA |
| Catalog Number | 149825003 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 788687 |
| Manufacturer | DEPUY ORTHOPAEDICS, DEPUY-CORK |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CTY, CORK EI |
| Baseline Brand Name | PRSVN MB TIB TRAY RM/LL CEM S3 |
| Baseline Generic Name | KNEE INSERT |
| Baseline Model No | NA |
| Baseline Catalog No | 149825003 |
| Baseline ID | NA |
| Baseline Device Family | PRSVN MB INSERT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9100 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-02 |