PINNACLE MTL INS NEUT40IDX58OD
Report
- Report Number
- 1818910-2011-16024
- Event Type
- Injury
- Date Received
- August 19, 2011
- Report Date
- July 21, 2011
- Manufacturer
- DEPUY ORTHOPAEDIC INC, 1818910
- Product Code
- KWA
- PMA / PMN Number
- K062426
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
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. H10 ADDITIONAL NARRATIVE: NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE PATIENT HAS BEEN CAUSED TO SUSTAIN SERIOUS INJURIES; HAS SUFFERED AND WILL CONTINUE TO SUFFER GREAT PAIN OF BODY AND MIND; HAS BEEN AND WILL IN THE FUTURE BE DEPRIVED OF EARNINGS AND EARNING CAPACITY; HAS SUSTAINED PERMANENT DISABILITY AND DEFORMITY; HAS BEEN CAUSED GREAT INCONVENIENCE, AND HAS INCURRED AND WILL IN THE FUTURE INCUR HOSPITAL, DOCTORS' AND/OR RELATED EXPENSES IN AN EFFORT TO TREAT AND/OR BE CURED OF SAID INJURIES. UPDATE 11/19/2012-MEDICAL RECORDS RECEIVED. MEDICAL RECORDS INDICATE PART/LOT. MEDICAL RECORDS ARE LOCATED ON THE EXTERNAL HARD DRIVE. DOI: 05/05/2009 - DOR: NONE REPORTED (LEFT SIDE). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
THIS FOLLOW-UP WAS MADE IN ERROR.
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 CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: UDI: (B)(4). ADDED: D1, D2, D4, G5, H4 AND H6(PATIENT).
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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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 WILL BE FILED AS APPROPRIATE.
THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP IS BEING SUBMITTED TO FILL THE GAP IN FOLLOW-UP SEQUENCE NUMBERS.
COMPLAINT DESCRIPTION: NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE PATIENT HAS BEEN CAUSED TO SUSTAIN SERIOUS INJURIES; HAS SUFFERED AND WILL CONTINUE TO SUFFER GREAT PAIN OF BODY AND MIND; HAS BEEN AND WILL IN THE FUTURE BE DEPRIVED OF EARNINGS AND EARNING CAPACITY; HAS SUSTAINED PERMANENT DISABILITY AND DEFORMITY; HAS BEEN CAUSED GREAT INCONVENIENCE, AND HAS INCURRED AND WILL IN THE FUTURE INCUR HOSPITAL, DOCTORS' AND/OR RELATED EXPENSES IN AN EFFORT TO TREAT AND/OR BE CURED OF SAID INJURIES. UPDATE 11/19/2012-MEDICAL RECORDS RECEIVED. MEDICAL RECORDS INDICATE PART/LOT. MEDICAL RECORDS ARE LOCATED ON THE EXTERNAL HARD DRIVE. UPDATE AD 20 APRIL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF RECEIVED. THERE IS NO NEW ALLEGATION AND REVISION REPORTED. ADDED LAWYER AND LAW FIRM. DOI: MAY 5, 2009 - DOR: NOT REPORTED (LEFT HIP).
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE OTHER REPORTED INCIDENT AGAINST LOT 2842431 AND OTHER REPORTED INCIDENTS AGAINST LOT 2868410 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
LITIGATION PAPERS ALLEGE PT HAS BEEN CAUSED TO SUSTAIN SERIOUS INJURIES; HAS SUFFERED AND WILL CONTINUE TO SUFFER GREAT PAIN OF BODY AND MIND; HAS BEEN AND WILL IN THE FUTURE BE DEPRIVED OF EARNINGS AND EARNING CAPACITY; HAS SUSTAINED PERMANENT DISABILITY AND DEFORMITY; HAS BEEN CAUSED GREAT INCONVENIENCE, AND HAS INCURRED AND WILL IN THE FUTURE INCUR HOSPITAL, DOCTORS' AND/OR RELATED EXPENSES IN AN EFFORT TO TREAT AND/OR BE CURED OF SAID INJURIES.
LITIGATION PAPERS ALLEGE, PATIENT HAS BEEN CAUSED TO SUSTAIN SERIOUS INJURIES; HAS SUFFERED AND WILL CONTINUE TO SUFFER GREAT PAIN OF BODY AND MIND; HAS BEEN AND WILL IN THE FUTURE BE DEPRIVED OF EARNINGS AND EARNING CAPACITY; HAS SUSTAINED PERMANENT DISABILITY AND DEFORMITY; HAS BEEN CAUSED GREAT INCONVENIENCE, AND HAS INCURRED AND WILL IN THE FUTURE INCUR HOSPITAL, DOCTORS AND/OR RELATED EXPENSES IN AN EFFORT TO TREAT AND/OR BE CURED OF SAID INJURIES. UPDATE: (B)(6) 2012-MEDICAL RECORDS RECEIVED . MEDICAL RECORDS INDICATE PART/LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15296 | PINNACLE MTL INS NEUT40IDX58OD | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS | KWA | DEPUY ORTHOPAEDIC INC, 1818910 | NA | 2842431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | NA. |