FDA Adverse Event
Injury
Summary report: N
9612771-2006-00025
MDR report key: 764261
·
Received September 1, 2006
Report
- Report Number
- 9612771-2006-00025
- Event Type
- Injury
- Date Received
- September 1, 2006
- Product Code
- KWB
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE SUBJECT IMPLANT WAS DISPLACED DURING THE FALL AND DISLOCATION. IT WAS REPOSITIONED BUT NOT REPLACED. NO DEVICE WAS RETURNED TO PLUS ORTHOPEDICS USA SO A DEVICE EVAL CANNOT BE PERFORMED. CONCLUSIONS: THE SURGEON HAS INDICATED TO PLUS ORTHOPEDICS USA THAT HE DOES NOT BELIEVE PLUS PRODUCTS CAUSED OR CONTRIBUTED TO THE PT'S CONDITION. LITERATURE CITATION: ON THE SECOND PAGE OF THE ATTACHED ARTICLE, IN THE SECOND FULL PARAGRAPH THE SURGEON'S OBSERVATION IS, "I EXPERIENCED A SIGNIFICANT LEARNING CURVE WITH 1.2% DISLOCATIONS AND 1.6% REOPERATIONS BUT, SOMEWHAT UNIQUE IN AN EARLY EXPERIENCE OF MIS HIP REPLACEMENT, THERE WERE NO INTRAOPERATIVE FRACTURES AND NO NERVE DAMAGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KWB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |