FDA Adverse Event
Malfunction
Summary report: N
TRUFIT CB PLUG KITS
MDR report key: 1880435
·
Received October 22, 2010
Report
- Report Number
- 1219602-2010-00250
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Report Date
- May 14, 2010
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
- Product Code
- MQV
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT BEING RETURNED FOR EVALUATION. (B)(4) WAS NOTIFIED OF INCIDENT IN (B)(6), 2010 HOWEVER THE INFORMATION WAS NOT FORWARDED TO MANSFIELD QUALITY GBU UNTIL (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
PATIENT EXPERIENCED POST-OP CONDITION WITH GREAT KNEE PAIN AROUND ONE YEAR AFTER THE TRUFIT IMPLANT. SURGEON DID A SECOND LOOK AND DISCOVER A QUITE PERFECT CARTILAGE REPAIRING BUT INVESTIGATING WITH A PROBE, UNDER A VERY THIN LAYER THEY DISCOVER THE ORIGINAL HOLE WITH SOMETHING INSIDE THEY DEFINED 'TOOTHPASTE'. THEY ALSO DO FURTHER INVESTIGATIONS ON THE SPECIMEN OF THESE MATERIALS AND WHILE THE 'TOOTHPASTE' WAS SOMETHING AMORPHOUS THE LAYER WAS HYALINE CARTILAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFIT CB PLUG KITS | TRUFIT DEVICE | MQV | SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |