MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-07-17 for MICRO-UNI TRAY29 R/L 869085 manufactured by Depuy-raynham, A Division Of Depuy Orthopaedics, Inc.
[877239]
The pt was revised because of osteolysis, wear and loosening.
Patient Sequence No: 1, Text Type: D, B5
[8084945]
Eval was not possible, as the product was not returned. Product info required to review the device history records was not provided. The investigation was limited to the info provided. The investigation could not verify or draw any conclusions about reported polyethylene wear or device loosening. The length of time implanted could be a contributing factor. Based on the investigation findings, the need for corrective action is not indicated. In addition, the product is a discontinued item. Depuy considers the investigation closed at this time. Should the product and/or add'l info be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2008-02957 |
| MDR Report Key | 1078712 |
| Report Source | 05,07 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-06-17 |
| Date of Event | 2008-06-17 |
| Date Mfgr Received | 2008-06-17 |
| Date Added to Maude | 2008-07-24 |
| 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 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY-RAYNHAM, A DIVISIONOF DEPUY ORTHOPAEDICS, IN |
| 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 | MICRO-UNI TRAY29 R/L |
| Generic Name | 87KYK |
| Product Code | KYK |
| Date Received | 2008-07-17 |
| Model Number | NA |
| Catalog Number | 869085 |
| Lot Number | UNK |
| 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 | 1046036 |
| Manufacturer | DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 027670350 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-17 |