AS VEGA PS TIBIAL PLATEAU CEMENTED T2
Report
- Report Number
- 9610612-2018-00162
- Event Type
- Malfunction
- Date Received
- April 3, 2018
- Date of Event
- November 10, 2017
- Report Date
- June 14, 2018
- Manufacturer
- AESCULAP AG
- Product Code
- JWH
- PMA / PMN Number
- K101281
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.
INVESTIGATION: NO PRODUCT IS AT HAND. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LOT NUMBERS (52142575, 52128834, 51870728, 52134791) AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM BATCH 52128834 AND 52134791. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THE OTHER BATCHES. CONCLUSION AND ROOT CAUSE: NO PRODUCT AVAILABLE, AND THEREFORE A COMPLETE ANALYSIS IS NOT POSSIBLE, BUT BASED ON THE INFORMATION AVAILABLE, IT APPEARS THE ROOT CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THERE IS THE POSSIBILITY THAT THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE OR PATIENT RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. UNFORTUNATELY DUE TO A LACK OF DATA AND WITHOUT THE PRODUCT WE CAN NOT DETERMINE THE EXACT CAUSE. CORRECTIVE ACTION: PRODUCT SAFETY CASE (B)(4). ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE.
ADDITIONAL INFORMATION PROVIDED: EVENT: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: AS VEGA PS TIBIAL PLATEAU CEMENTED T2, NN261Z / AS TIBIAL OBTURATOR D12MM, NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM. BRAND NAME:AS VEGA PS TIBIAL PLATEAU CEMENTED T2. MODEL AND CATALOG # NX053Z. EXPIRATION DATE: 04/30/2015. 34 MONTHS. PMA/510K: K101281.
ADDITIONAL INFORMATION PROVIDED: DESCRIBE EVENT OR PROBLEM. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: AS VEGA PS TIBIAL PLATEAU CEMENTED T2 NN261Z / AS TIBIAL OBTURATOR D12MM NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM. BRAND NAME:AS VEGA PS TIBIAL PLATEAU CEMENTED T2. MODEL AND CATALOG # NX053Z. EXPIRATION DATE:04/30/2015. CONCOMITANT MEDICAL PRODUCTS. ADDED COMPONENTS. APPROX. AGE OF DEVICE. 34 MONTHS. PMA/510K. K101281.
COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075165): EVENT DESCRIPTION PER MW REPORT: TOTAL KNEE LOOSENING 80 FEMUR 90% TIBIA, REVISED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. ALL MED WATCH SUBMISSIONS TO THIS REPORT ARE: 9610612-2018-00154.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: AS VEGA PS TIBIAL PLATEAU CEMENTED T2, NN261Z / AS TIBIAL OBTURATOR D12MM, NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: AS VEGA PS TIBIAL PLATEAU CEMENTED T2 NN261Z / AS TIBIAL OBTURATOR D12MM NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236416 | AS VEGA PS TIBIAL PLATEAU CEMENTED T2 | FEMUR IMPLANTS VEGA SYSTEM | JWH | AESCULAP AG | NX053Z | 52142575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | AS VEGA PS TIBIAL PLATEAU CEMENTED T2| AS VEGA PS TIBIAL PLATEAU CEMENTED T2| NN261Z / AS TIBIAL OBTURATOR D12MM| NN261Z / AS TIBIAL OBTURATOR D12MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM| NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM |