PINNACLE 100 ACET CUP 56MM
Report
- Report Number
- 1818910-2017-18793
- Event Type
- Injury
- Date Received
- May 30, 2017
- Date of Event
- April 7, 2016
- Report Date
- December 27, 2016
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- PMA / PMN Number
- K001534
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NOTIFICATION WAS RECEIVED 08-MARCH-19 ADVISING: "UPDATE AD 08 MAR 2019. (B)(4) IS A REOPEN OF COM-250037 DUE TO RECEIPT OF AN EMAIL NOTIFICATION FROM KENNEDYS. THERE ARE NO NEW ALLEGATIONS. THE CLAIM IS NOW ACTIVELY LITIGATED." REVIEW OF THE NOTIFICATION IDENTIFIED THAT THERE WAS NO NEW INFORMATION AND NO NEW ALLEGATIONS. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. H6 COMPONENT CODE: PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE (G07001) IS USED TO CAPTURE PRODUCT NOT RETURNED.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NOTIFICATION WAS RECEIVED 08-MARCH-19 ADVISING: "UPDATE AD 08 MAR 2019. (B)(4) IS A REOPEN OF COM-250037 DUE TO RECEIPT OF AN EMAIL NOTIFICATION FROM KENNEDYS. THERE ARE NO NEW ALLEGATIONS. THE CLAIM IS NOW ACTIVELY LITIGATED." REVIEW OF THE NOTIFICATION IDENTIFIED THAT THERE WAS NO NEW INFORMATION AND NO NEW ALLEGATIONS. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. H6 COMPONENT CODE: PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE (G07001) IS USED TO CAPTURE PRODUCT NOT RETURNED. H6 INVESTIGATION CONCLUSIONS CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (D17) USED TO CAPTURE UNDETERMINED AS PRODUCT WAS NOT RETURNED.
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. PATIENT CODE: NO CODE AVAILABLE (3191) IS USED TO CAPTURE DEVICE REVISION OR REPLACEMENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NOTIFICATION WAS RECEIVED 08-MARCH-19 ADVISING: "UPDATE AD 08 MAR 2019. (B)(4) IS A REOPEN OF (B)(4) DUE TO RECEIPT OF AN EMAIL NOTIFICATION FROM KENNEDYS. THERE ARE NO NEW ALLEGATIONS. THE CLAIM IS NOW ACTIVELY LITIGATED." REVIEW OF THE NOTIFICATION IDENTIFIED THAT THERE WAS NO NEW INFORMATION AND NO NEW ALLEGATIONS. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
NEW ECM RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT UNDER (B)(4) LAWYER IS CLAIMING FOR COMPENSATION BECAUSE OF FRACTURE OF CERAMIC HIP HEAD RIGHT SIDE. DOI: (B)(6) 2015, DOR: (B)(6) 2016. UPDATE 4-MAY-2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, FRACTURED LINER (NOT FEMORAL HEAD), GRATING SENSATION, METALLOSIS, AND WEAR ON THE SOCKET EDGE OF THE LINER. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. PART/LOT WAS PROVIDED AND UPDATED AND LINER WAS ADDED TO THE COMPLAINT. THE LINER, CUP, AND HEAD ARE BEING REPORTED. THIS COMPLAINT WAS UPDATED ON: 30-MAY-2017. UPDATE AD 08 MAR 2019. (B)(4) IS A REOPEN OF (B)(4) DUE TO RECEIPT OF AN EMAIL NOTIFICATION FROM KENNEDYS. THERE ARE NO NEW ALLEGATIONS. THE CLAIM IS NOW ACTIVELY LITIGATED. DOI: (B)(6) 2015 - DOR: (B)(6) 2016 (RIGHT HIP). THIS COMPLAINT WAS UPDATED ON 08 MAR 2019.
THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
LAWYER IS CLAIMING FOR COMPENSATION BECAUSE OF FRACTURE OF CERAMIC HIP HEAD RIGHT SIDE. DOI: (B)(6) 2015, DOR: (B)(6) 2016. UPDATE 4-MAY-2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, FRACTURED LINER (NOT FEMORAL HEAD), GRATING SENSATION, METALLOSIS, AND WEAR ON THE SOCKET EDGE OF THE LINER. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. PART/LOT WAS PROVIDED AND UPDATED AND LINER WAS ADDED TO THE COMPLAINT. THE LINER, CUP, AND HEAD ARE BEING REPORTED. THIS COMPLAINT WAS UPDATED ON: 30-MAY-2017. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
LAWYER IS CLAIMING FOR COMPENSATION BECAUSE OF FRACTURE OF CERAMIC HIP HEAD RIGHT SIDE. DOI (B)(6) 2015, DOR (B)(6) 2016. UPDATE 4-MAY-2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, FRACTURED LINER (NOT FEMORAL HEAD), GRATING SENSATION, METALLOSIS, AND WEAR ON THE SOCKET EDGE OF THE LINER. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. PART/LOT WAS PROVIDED AND UPDATED AND LINER WAS ADDED TO THE COMPLAINT. THE LINER, CUP, AND HEAD ARE BEING REPORTED. THIS COMPLAINT WAS UPDATED ON: 30-MAY-2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379140 | PINNACLE 100 ACET CUP 56MM | HIP ACETABULAR CUP | LPH | DEPUY ORTHOPAEDICS INC US | 7914432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | CORAIL2 NON COL HO SIZE 13| DELTA CER HEAD 12/14 36MM +5| DELTA CER INSERT 36ID X 56OD |