AS VEGA PS FEMORAL COMP.CEMENTED F4N L
Report
- Report Number
- 9610612-2018-00154
- 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.
ADDITIONAL INFORMATION PROVIDED: EVENT. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX009Z / AS VEGA PS FEMORAL COMP. CEMENTED F4N L, 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 FEMORAL COMP. CEMENTED F4N L. MODEL AND CATALOG#: NX009Z. EXPIRATION DATE: 04/30/2015. ADDED COMPONENTS: 34 MONTHS. PMA/510K: K101281.
INVESTIGATION: NO PRODUCT IS AT HAND. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LOT NUMBERS (52137600, 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 17-19. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE.
ADDITIONAL INFORMATION PROVIDED: EVENT: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX009Z / AS VEGA PS FEMORAL COMP. CEMENTED F4N L, 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 FEMORAL COMP. CEMENTED F4N L. MODEL AND CATALOG#: NX009Z. EXPIRATION DATE: 04/30/2015. 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: 9610612-2018-00162.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX009Z / AS VEGA PS FEMORAL COMP. CEMENTED F4N L, 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: NX009Z / AS VEGA PS FEMORAL COMP. CEMENTED F4N L, 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 |
|---|---|---|---|---|---|---|---|
| 236413 | AS VEGA PS FEMORAL COMP.CEMENTED F4N L | FEMUR IMPLANTS VEGA SYSTEM | JWH | AESCULAP AG | NX009Z | 52137600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | NN261Z / AS TIBIAL OBTURATOR D12MM| NN261Z / AS TIBIAL OBTURATOR D12MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L| NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L| NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM| NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM |