FDA Adverse Event
Injury
Summary report: N
MCK ONLY INSERT
MDR report key: 1811985
·
Received August 6, 2010
Report
- Report Number
- 3005985723-2010-00016
- Event Type
- Injury
- Date Received
- August 6, 2010
- Date of Event
- July 8, 2010
- Report Date
- August 6, 2010
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- HSX
- PMA / PMN Number
- K082081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE IMPLANT POLY WAS REMOVED AND REPLACED DURING A PROCEDURE TO REMOVE EXCESS FLUID. THIS DECISION WAS MADE PRE-OP, AND WAS NOT THE RESULT OF PAIN OR ANY CONCERN ON THE IMPLANT PERFORMANCE. UPON INSPECTION, THE POLY HAD A NON-NORMAL WEAR PATTERN. THE ROOT CAUSE OF THIS WEAR PATTERN IS BEING INVESTIGATED, AND NO CONCLUSION HAS BEEN MADE TO DATE. THIS WAS NOT THE CAUSE OF THE REVISION, IT WAS SIMPLY AN OBSERVATION POST-OP. THIS MDR IS BEING FILED AS THE INVESTIGATION IS NOT COMPLETE AT THE REQUIRED FILING DATE.
Description of Event or Problem · 1
REVISION TO PLACE SCREWS TO REATTACH MEDIAL TIBIAL PLATEAU TO THE REST OF THE TIBIAL PLATEAU, DUE TO POST-OPERATIVE FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MCK ONLY INSERT | UNICONDYLAR KNEE SYSTEM | HSX | MAKO SURGICAL CORP. | 180704-1 | 12130209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |