PINN SECTOR W/GRIPTION 48MM
Report
- Report Number
- 1818910-2021-05500
- Event Type
- Malfunction
- Date Received
- March 18, 2021
- Date of Event
- March 1, 2021
- Report Date
- March 1, 2021
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KWA
- UDI-DI
- 10603295010289
- PMA / PMN Number
- K093646
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # ==>(B)(4) INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED OBSERVATION. THE ROOT CAUSE IS RELATED TO MANUFACTURE OF THE ACETABULAR CUP. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> NONCONFORMANCE REPORT (NR)-0152452 WAS ESTABLISHED TO FURTHER INVESTIGATE ROOT CAUSE AND CORRECTIVE ACTION, AS APPROPRIATE, ASSOCIATED WITH THE ACETABULAR CUP(S). BECAUSE OF THE EXPANDED INVESTIGATION IT IS KNOWN THAT THIS CUP PRODUCT/LOT COMBINATION IS ONE THAT WAS IDENTIFIED AS HAVING BEEN NEGATIVELY AFFECTED DURING THE MANUFACTURING PROCESS. MRE NOT PERFORMED. CORRECTED: H3
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO ADVERSE AFFECTS TO REPORT OTHER THAN EXTENDED SURGERY TIME. THE WAS A DEFECTIVE CUP AS STATED. THE APEX HOLE WAS TO BIG ALLOWING RESIDENTS HOLE ELIMINATOR TO SCREW ALL THE WAY THROUGH THE CUP. THE AFFECTED SIDE WAS THE LEFT SIDE. NO INSTRUMENTATION WAS BROKEN. THIS WAS AN IMPLANT ISSUE AS STATED IN ORIGINAL REPORT.
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT A 48 MM CUP HAD A APEX HOLE THAT WAS MILLED INCORRECTLY. THIS ALLOWED APEX HOLE ELIMINATOR TO SCREW ALL THE WAY THROUGH IT. HAD TO TAKE THE CUP OUT AND WASTED A LINER A SCREW AND APEX. HE THEN IMPLANTED A NEW CUP APEX AND LINER. 15 MINS SURGICAL DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409760 | PINN SECTOR W/GRIPTION 48MM | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS | KWA | DEPUY ORTHOPAEDICS INC US | 1217-32-048 | 9618493 | 10603295010289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | ALTRX +4 NEUT 32IDX48OD| APEX HOLE ELIM POSITIVE STOP| PINN CAN BONE SCREW 6.5MMX40MM| PINN SECTOR W/GRIPTION 48MM| ALTRX +4 NEUT 32IDX48OD| APEX HOLE ELIM POSITIVE STOP| PINN CAN BONE SCREW 6.5MMX40MM| PINN SECTOR W/GRIPTION 48MM |