MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-08-06 for MIC TIB TRAY 26MM R 869083 manufactured by Depuy-raynham / A Div Of Depuy Orthopaedics, Inc..
[19492680]
The pt was revised because of poly wear and metalosis.
Patient Sequence No: 1, Text Type: D, B5
[19746191]
Examination was not possible as no product was returned. Although the exact root cause could not be determined, it would not be unreasonable to expect some wear after approx. 15 years of implantation. The need for corrective action is not indicated. The product codes provided are obsolete items.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2007-02328 |
| MDR Report Key | 891372 |
| Report Source | 05,07 |
| Date Received | 2007-08-06 |
| Date of Report | 2007-07-09 |
| Date of Event | 2007-07-09 |
| Date Mfgr Received | 2007-07-09 |
| Date Added to Maude | 2007-08-14 |
| 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 | GINNY STAMBERGER, MGR. |
| Manufacturer Street | 700 ORHTOPAEDICS, INC. |
| 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 | MIC TIB TRAY 26MM R |
| Generic Name | 87KYK |
| Product Code | KYK |
| Date Received | 2007-08-06 |
| Model Number | NA |
| Catalog Number | 869083 |
| Lot Number | A65X7 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 870076 |
| 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 | 2007-08-06 |