MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for TITANIUM ELBOW IMPLANT COMPONENT manufactured by Zimmer, Inc..
[8724]
Four yrs ago, rptr had a customized elbow titanium implant with modified ulnar component. Rptr is and has been in constant pain every day every min since she had this surgery. She can get no help from any surgeon she's seen the past four yrs. No one will touch it to give her relief. Rptr is not only in pain, but her arm is becoming atrofied and she is loosing the use of her hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000235 |
| MDR Report Key | 11562 |
| Date Received | 1994-02-07 |
| Date of Report | 1993-08-27 |
| Date Added to Maude | 1994-02-22 |
| 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 | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TITANIUM ELBOW IMPLANT COMPONENT |
| Product Code | KWJ |
| Date Received | 1994-02-07 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11562 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-07 |