MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2007-02-15 for MBT CEM KEEL TIB TRAY SZ3 149825004 manufactured by Depuy Orthopaedics, Depuy-cork.
[590798]
Pt was revised to address subsidence of the tibial component.
Patient Sequence No: 1, Text Type: D, B5
[7820562]
Evaluation was not possible, as the device was not returned. Review of the device history records did not reveal any anomalies. The investigation could not verify or draw any conclusions about the reported event; however, no evidence was found that suggests product error was a contributing factor. Based on the investigation findings, the need for corrective action is not indicated. Should add'l info be received, the complaint will be reopened. Depuy considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2007-00345 |
| MDR Report Key | 819512 |
| Report Source | 05,08 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-01-17 |
| Date of Event | 2007-01-17 |
| Date Mfgr Received | 2007-01-17 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2007-02-23 |
| 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 COUNTY, 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 | MBT CEM KEEL TIB TRAY SZ3 |
| Generic Name | 87MBD |
| Product Code | MBD |
| Date Received | 2007-02-15 |
| Model Number | NA |
| Catalog Number | 149825004 |
| Lot Number | 1077582 |
| 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 | 807000 |
| Manufacturer | DEPUY ORTHOPAEDICS, DEPUY-CORK |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CTY, CORK EI |
| Baseline Brand Name | PRSVN MB TIB TRAY RM/LL CEM S4 |
| Baseline Generic Name | KNEE INSERT |
| Baseline Model No | NA |
| Baseline Catalog No | 149825004 |
| 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 | 2007-02-15 |