MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-04-24 for UNKNOWN DEPUY HIP LINER manufactured by Depuy Orthopaedics, Inc..
[627960]
The pt was revised because of poly wear.
Patient Sequence No: 1, Text Type: D, B5
[7927534]
Examination was not possible, as the device was not returned. Review of the device history records was also not possible as the product and lot code was unavailable. The investigation could not verify or identify any evidence of product contribution to the reported event with the info available. Based on the investigation, the need for corrective action is not indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2007-01374 |
| MDR Report Key | 842135 |
| Report Source | 05,07 |
| Date Received | 2007-04-24 |
| Date of Report | 2007-04-17 |
| Date of Event | 2007-04-17 |
| Date Mfgr Received | 2007-04-17 |
| Date Added to Maude | 2007-05-01 |
| 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, 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 HIP LINER |
| Generic Name | TOTAL HIP PROSTHESIS |
| Product Code | LFH |
| Date Received | 2007-04-24 |
| Model Number | NA |
| Catalog Number | UNK |
| 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 | 829396 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-24 |