FDA Adverse Event
Injury
Summary report: N
PK/5 NAVIGATION PIN 3MMX100MM
MDR report key: 1171097
·
Received September 19, 2008
Report
- Report Number
- 8010177-2008-00065
- Event Type
- Injury
- Date Received
- September 19, 2008
- Date of Event
- August 14, 2006
- Report Date
- August 14, 2006
- Manufacturer
- STRYKER NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K022365
- Removal / Correction Number
- 18117556/5/2008-001C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR EVAL. A RECALL WAS INITIATED ON THE INSTRUCTIONS FOR USE FOR THESE PINS. THE INSTRUCTIONS FOR USE WAS REVISED TO INCLUDE NEW WARNINGS REGARDING ASPECTS OF PIN PLACEMENT IN THE FEMUR AND TIBIA.
Description of Event or Problem · 1
SURGEON REPORTED THAT 3 MONTHS POST OP TKA, PT PRESENTED WITH PAIN IN HER TIBIA AND UNABLE TO BEAR WEIGHT. X-RAYS WERE TAKEN IN THE ER AND SHOWED A STRESS REACTION. AN MRI SHOWED A STRESS FRACTURE PROXIMAL TO MID TIBIA BELOW THE PROSTHESIS WITH EDEMA. THE FRACTURE WAS TREATED BY NON-OPERATIVE MEANS SUCH AS PROTECTED WEIGHT BEARING, BRACING AND EXTERNAL BONE STIMULATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PK/5 NAVIGATION PIN 3MMX100MM | STEREOTAXIC INSTRUMENT | HAW | STRYKER NAVIGATION | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |