METHA NECK 12/14 135°/0°
Report
- Report Number
- 9610612-2018-00030
- Event Type
- Malfunction
- Date Received
- February 27, 2018
- Date of Event
- January 13, 2018
- Report Date
- June 25, 2018
- Manufacturer
- AESCULAP IMPLANT SYSTEMS
- Product Code
- LWJ
- PMA / PMN Number
- K071916
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: ACCORDING TO THE PROVIDED INFORMATION, IT CAME TO A BREAKAGE OF THE METHA NECK ADAPTER POST OPERATIVELY AFTER THE PATIENT SPINS DURING STANDING. THE BREAKAGE OCCURRED (B)(6) 2018. THE PRIMARY SURGERY DATE WAS NOT SUBMITTED. THEREFORE IMPLANTATION PERIOD IS UNKNOWN. PRODUCT WAS NOT RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF A MATERIAL FAILURE OR A MANUFACTURING DEFECT. THE FAILURE IS MOST PROBABLY NOT PRODUCT RELATED. DUE TO THE FACT THAT THE PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. A CLEAR CONCLUSION CAN NOT BE DRAWN. THE PRODUCT IS NOT ON THE MARKET SINCE 2017. A CAPA IS NOT NECESSARY.
ADDITIONAL INFORMATION: EVENT PROBLEM: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NC087T / METHA NECK 12/14 135°/7.5°L ANTE-R RETRO. NC083T / METHA SHORT HIP STEM CAP SIZE 3. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. CONCOMITANT MEDICAL PRODUCTS: NC087T / METHA NECK 12/14 135°/7.5°L ANTE-R RETRO. NC083T / METHA SHORT HIP STEM CAP SIZE 3. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS.
ADDITIONAL INFORMATION : EVENT PROBELM: COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NC088K / METHA NECK 12/14 135°/0°. NC083T / METHA SHORT HIP STEM, CAP SIZE 3. CONCOMITANT MEDICAL PRODUCTS: NC088K / METHA NECK 12/14 135°/0°. NC083T / METHA SHORT HIP STEM CAP SIZE 3.
COUNTRY OF COMPLAINT: (B)(6). SPONTANEOUS FRACTURE OF THE PROSTHESIS WHEN TURNING FROM A STANDING POSITION.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NC087T / METHA NECK 12/14 135°/7.5°L ANTE-R RETRO. NC083T / METHA SHORT HIP STEM ¿CAP SIZE 3. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS. AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM COMPETITORS.
COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: NC088K / METHA NECK 12/14 135°/0°. NC083T / METHA SHORT HIP STEM, CAP SIZE 3.
CORRECTION: SUBMISSION SUBMITTED IN ERROR. THIS IS NOT USA PRODUCT. NO FOLLOW UP INFORMATION IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143209 | METHA NECK 12/14 135°/0° | HIP ENDOPROSTHETICS | LWJ | AESCULAP IMPLANT SYSTEMS | NC087T | 51254974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other | AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C| AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C| AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C| AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C| NC083T / METHA SHORT HIP STEM, CAP SIZE 3| NC083T / METHA SHORT HIP STEM, CAP SIZE 3| NC087T / METHA NECK 12/14 135°/7.5°L ANTE-R RETRO| NC088K / METHA NECK 12/14 135°/0° |