MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2006-09-18 for UNKNOWN DEPUY TIBIAL INSERT manufactured by Depuy Orthopaedics, Inc..
[528530]
Patient was revised due to poly wear.
Patient Sequence No: 1, Text Type: D, B5
[7835762]
Evaluation was not possible, as the product was not returned. The investigation was limited to the information provided, as the product code and lot numbers required to review the device history records and complaint history were not provided. The investigation could not verify or draw any conclusions about the reported event based on the provided information. It would not be unreasonable to expect some wear after 10 years of implantation. The initial report states that it is not suspected that the product failed to meet specifications or contributed to the reported event. The need for corrective action is not indicated. Should additional information be received, the complaint will be reopened. Depuy considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2006-02717 |
| MDR Report Key | 763284 |
| Report Source | 05,08 |
| Date Received | 2006-09-18 |
| Date of Report | 2006-08-22 |
| Date of Event | 2006-08-22 |
| Date Facility Aware | 2006-08-22 |
| Report Date | 2006-08-22 |
| Date Mfgr Received | 2006-08-22 |
| Date Added to Maude | 2006-09-25 |
| 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 | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY TIBIAL INSERT |
| Generic Name | TOTAL KNEE REPLACEMENT |
| Product Code | JHW |
| Date Received | 2006-09-18 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 751179 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-18 |