D
Patient 1
IT HAS BEEN REPORTED REVISION SURGERY PERFORMED DUE TO DISSOCIATED LINER.
MAUDE MDR 244816
- MDR report key
- 244816
- Report number
- 2243265-1999-00052
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-09-07
- Date received
- 1999-10-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LARRY BOOROM
- Address
- 30 MONROE ST. BINGHAMTON NY 13904 US
- Phone
- 607-607-6077
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OSTEONICS CONSTRAINED ACETABULAR INSERT | IMPLANT | HOWMEDICA INC. | KWB | NA | 2099-2254 | 37981901 | K980197 | Y | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1999-10-11 | 0 | 1. R |