AS VEGA PS FEMORAL COMP.CEMENTED F5N R
Report
- Report Number
- 9610612-2018-00131
- Event Type
- Malfunction
- Date Received
- March 23, 2018
- Report Date
- June 13, 2018
- Manufacturer
- AESCULAP IMPLANT SYSTEMS
- 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.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX031Z / AS VEGA PS FEMORAL COMP.CEMENTED F5N R; NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+; NN261Z / AS TIBIAL OBTURATOR D12MM; NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM; NX042 / PATELLA 3-PEGS P2. BRAND NAME: NX031Z. COMMON DEVICE NAME: AS VEGA PS FEMORAL COMP.CEMENTED F5N R. MODEL AND CATALOG # 52273744, EXPIRATION DATE: 04/31/2026. CONCOMITANT MEDICAL PRODUCTS: ADDED COMPONENTS. APPROX. AGE OF DEVICE: 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 OTHER LOT NUMBERS (52273744, 52236348, 52277568, 52217526, 52259408) AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM BATCH 52277568 AND 52259408. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM ANY OF 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 OR 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: DESCRIBE EVENT OR PROBLEM: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX031Z / AS VEGA PS FEMORAL COMP. CEMENTED F5N R NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+ NN261Z / AS TIBIAL OBTURATOR D12MM NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM NX042 / PATELLA 3-PEGS P2. BRAND NAME: NX031Z. COMMON DEVICE NAME: AS VEGA PS FEMORAL COMP. CEMENTED F5N R MODEL AND CATALOG # 52273744 EXPIRATION DATE: 04/31/2026. CONCOMITANT MEDICAL PRODUCTS. ADDED COMPONENTS APPROX. AGE OF DEVICE. 34 MONTHS PMA/510: K101281.
COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017, BUT THE SURGEON NOTICED THAT THE TIBIA HAD LOOSENED. REVISION SURGERY DATE IS (B)(6) 2018.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX031Z / AS VEGA PS FEMORAL COMP.CEMENTED F5N R; NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+; NN261Z / AS TIBIAL OBTURATOR D12MM; NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM; NX042 / PATELLA 3-PEGS P2.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX031Z / AS VEGA PS FEMORAL COMP. CEMENTED F5N R NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+ NN261Z / AS TIBIAL OBTURATOR D12MM NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM NX042 / PATELLA 3-PEGS P2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210498 | AS VEGA PS FEMORAL COMP.CEMENTED F5N R | FEMUR IMPLANTS VEGA SYSTEM | JWH | AESCULAP IMPLANT SYSTEMS | NX031Z | 52273744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | NN261Z / AS TIBIAL OBTURATOR D12MM| NN261Z / AS TIBIAL OBTURATOR D12MM| NX031Z / AS VEGA PS FEMORAL COMP.CEMENTED F5N R| NX031Z / AS VEGA PS FEMORAL COMP.CEMENTED F5N R| NX042 / PATELLA 3-PEGS P2| NX042 / PATELLA 3-PEGS P2| NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+| NX054Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2+| NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM| NX120 / VEGA PS GLIDING SURFACE T2/2+ 10MM |