MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-09 for PFC KNEE SYSTEM 96-0044 manufactured by Depuy.
[5695722]
My name is (b)(6). I am writing you in concern about my knee replacements. They have been giving me multiple problems. My right knee has been giving me the most problems. It is swollen and also turning dark. I am writing you because i think my knee replacement is the cause. The pain that my knees cause are unbearable. They ache and hurt every day. My doctor tells me that he doesn't know exactly what is wrong. I was wondering if there were any problems with the type of knee replacements i have. It would be really great if i could get down to the cause of my pain. I would also really like your help. Thank you.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041392 |
| MDR Report Key | 4603943 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-03-09 |
| Date Added to Maude | 2015-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFC KNEE SYSTEM |
| Generic Name | KNEE REPLACEMENT |
| Product Code | JWH |
| Date Received | 2015-03-09 |
| Model Number | 96-0044 |
| Lot Number | HX50744D |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Brand Name | MET TIBIAL TRAY |
| Generic Name | TIBIA |
| Product Code | JWH |
| Date Received | 2015-03-09 |
| Model Number | 129433130 |
| Lot Number | 2048700 |
| Device Expiration Date | 2011-01-01 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Brand Name | PATELLA |
| Generic Name | PATELLA |
| Product Code | HTG |
| Date Received | 2015-03-09 |
| Model Number | 96-0101 |
| Lot Number | 1927685 |
| Device Expiration Date | 2010-06-01 |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Brand Name | TIBIAL INSERT |
| Generic Name | INSERT |
| Product Code | JWH |
| Date Received | 2015-03-09 |
| Model Number | 96-2124 |
| Lot Number | 1862663 |
| Device Expiration Date | 2010-02-01 |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Brand Name | BONE CEMENT |
| Generic Name | CEMENT |
| Product Code | LOD |
| Date Received | 2015-03-09 |
| Model Number | 3102-040 |
| Lot Number | 2084464 |
| Device Expiration Date | 2008-01-01 |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Brand Name | PFC KNEE SYSTEM |
| Generic Name | KNEE REPLACEMENT |
| Product Code | JWH |
| Date Received | 2015-03-09 |
| Model Number | 96-0444 |
| Lot Number | 47606A |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-09 |