N
Patient 1
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 9824105
- MDR report key
- 9824105
- Report number
- 1818910-2020-07609
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-25
- Date received
- 2020-03-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. KARA DITTY-BOVARD
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
- Phone
- 610-610-6107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ANT BROACH HANDLE - R | HIP INSTRUMENTS : HANDLES | DEPUY ORTHOPAEDICS INC US | HTQ | 2598-07-360 | 259807360 | B0108 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-12 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP. DURING ASSEMBLY OF THE INSTRUMENTS AFTER THE SURGERY, IT WAS NOTICED THE OFFSET BROACH HANDLE WAS BROKEN. A PIECE WAS MISSING FROM THE LOCKING JUNCTION IN THE MIDDLE OF THE HANDLE. IT WAS UNKNOWN WHERE THE PIECE WAS, OR IF THE PIECE WAS LEFT IN THE PATIENT. NO SURGICAL DELAY.