MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-03-29 for UNKNOWN DEPUY FEMORAL ADAPTER BOLT manufactured by Depuy Orthopaedics, Inc..
[1888802]
Patient was revised to address broken femoral adapter and femoral adapter bolt, which caused metal debris to be generated. Knee became painful, and there were osteolytic changes because of the metal debris.
Patient Sequence No: 1, Text Type: D, B5
[8999005]
The product associated with this reported event was not returned for examination. The product code and lot code required in retrieving the device history records for reviewing and searching the complaint database were not provided. The investigation could not draw any conclusions about the reported event based on the lack of the product to examine and insufficient product information. Based on the performed investigation, the need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2011-05401 |
| MDR Report Key | 2035979 |
| Report Source | 05,08 |
| Date Received | 2011-03-29 |
| Date of Report | 2011-02-28 |
| Date of Event | 2011-02-28 |
| Date Mfgr Received | 2011-02-28 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2011-04-05 |
| 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 | KATHERINE SEPPA, 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 FEMORAL ADAPTER BOLT |
| Generic Name | TOTAL KNEE PROSTHESIS |
| Product Code | LYT |
| Date Received | 2011-03-29 |
| Model Number | NA |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46581098 US 46581 0988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-29 |