PINNACLE MTL INS NEUT36IDX54OD
Report
- Report Number
- 1818910-2012-19728
- Event Type
- Injury
- Date Received
- September 6, 2012
- Date of Event
- August 29, 2012
- Report Date
- August 29, 2012
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LZO
- PMA / PMN Number
- PK003523
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE 1092423. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1083201 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
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: ADDED: B5 D2 D6 F10 G3 G5 H4 H10 DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.
PRODUCT COMPLAINT # (B)(4). THIS FOLLOW-UP 2 REPORT IS BEING SUBMITTED IN ORDER TO NOTIFY THAT THE FOLLOW-UP NUMBER SEQUENCE OF 1818910-2012-19727 IS INCORRECT. THERE IS A GAP IN THE NUMBER SEQUENCE SINCE FOLLOW-UPS 2 AND 3 WERE MISSING. IF FUTURE SUPPLEMENTAL REPORTS ARE NEEDED, THEY THEN CONTINUE IN FOLLOW-UP 9 AND SO FORTH
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.
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. H10 ADDITIONAL NARRATIVE: CORRECTED: G2.
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: UDI: (B)(4). ADDED: H6(PATIENT, DEVICE) CORRECTED: A1.
PRODUCT COMPLAINT # (B)(4). 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: ADDED: H6(PATIENT CODE). H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE (MEDICAL DEVICE REMOVAL).
UPDATE (B)(6) 2015- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED OPTIC NERVE DAMAGE FROM METAL IONS, STIFFNESS, DIFFICULT/LIMITED MOBILITY, FALL (B)(6) 2011, BALANCE LOSS, METALLOSIS, DECREASED RANGE OF MOTION AND FIVE DISLOCATIONS FROM (B)(6) 2012 THROUGH 10/31/12. THE DISLOCATIONS WERE AFTER REVISION AND ARE REPORTED ON COM-(B)(4). THE REVISION SURGICAL REPORT NOTED ABUNDANT METAL STAINED TISSUE THAT WAS DEBRIDED AND THAT THE CUP WAS SLIGHTLY VERTICAL BUT NOT REVISED DUE TO THE BONY INGROWTH AND STABILITY. THE CUP WAS NOT ADDED TO COMPLAINT SINCE IT WAS NOT REVISED. THERE WAS NO REPORT OF GRINDING NOISE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2015.
PPF ALLEGES INFECTION, METAL WEAR, AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS EXTENSIVE METALLOSIS. REVISION NOTES HAD NO INFECTION REPORTED DURING THE FIRST REVISION.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. ONE PATIENT X-RAY WAS THE ONLY ADDITIONAL INFORMATION OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
PATIENT WAS REVISED TO ADDRESS PAIN, METALLOSIS, AND A GRINDING NOISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601791 | PINNACLE MTL INS NEUT36IDX54OD | ACETABULAR LINER | LZO | DEPUY ORTHOPAEDICS INC US | 1083201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |