AS VEGA PS TIBIAL PLATEAU CEMENTED T3
Report
- Report Number
- 9610612-2018-00159
- Event Type
- Malfunction
- Date Received
- April 4, 2018
- 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: NX055Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3, NN264Z / AS TIBIAL OBTURATOR D14MM, NX130 / VEGA PS GLIDING SURFACE T3/3+ 10MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM. BRAND NAME: NX055Z. COMMON DEVICE NAME: AS VEGA PS TIBIAL PLATEAU CEMENTED T3. MODEL AND CATALOG#: 52126958. EXPIRATION DATE: 02/28/2018. ADDED COMPONENTS: 34 MONTHS. PMA/510K: K101281.
ADDITIONAL INFORMATION PROVIDED: EVENT: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX055Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3, NN264Z / AS TIBIAL OBTURATOR D14MM, NX130 / VEGA PS GLIDING SURFACE T3/3+ 10MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM. BRAND NAME: NX055Z. COMMON DEVICE NAME: AS VEGA PS TIBIAL PLATEAU CEMENTED T3. MODEL AND CATALOG#: 52126958. EXPIRATION DATE: 02/28/2018. 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 AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THE 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.
COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075167): ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. MED /WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00146.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX055Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3, NN264Z / AS TIBIAL OBTURATOR D14MM, NX130 / VEGA PS GLIDING SURFACE T3/3+ 10MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NX055Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3, NN264Z / AS TIBIAL OBTURATOR D14MM, NX130 / VEGA PS GLIDING SURFACE T3/3+ 10MM, NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240711 | AS VEGA PS TIBIAL PLATEAU CEMENTED T3 | FEMUR IMPLANTS VEGA SYSTEM | JWH | AESCULAP AG | NX055Z | 52126958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | NN264Z / AS TIBIAL OBTURATOR D14MM| NN264Z / AS TIBIAL OBTURATOR D14MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NN483 / COLUMBUS PATELLA 3-PEGS P3 33X9MM| NX055Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3| NX055Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T3| NX130 / VEGA PS GLIDING SURFACE T3/3+ 10MM| NX130 / VEGA PS GLIDING SURFACE T3/3+ 10MM |