PINNACLE MTL INS NEUT36IDX56OD
Report
- Report Number
- 1818910-2008-04427
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- September 15, 2008
- Report Date
- July 23, 2013
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KWA
- PMA / PMN Number
- PK003523
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND LOT CODE WAS UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
UPDATE: (B)(6) 2013, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED BY INVOICE SEARCH. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
(B)(4).
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. 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. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE ADVERSE SYMPTOMS ALLEGED AND PRODUCT CODE REPORTED IS ASSOCIATED WITH THE DEPUY METAL ON METAL ARTICULATION. A COMPLAINT DATABASE SEARCH AND/OR DEVICE MANUFACTURING (DHR) REVIEWS WILL NOT BE PERFORMED. PER (B)(4) IT HAS BEEN DETERMINED THAT SHOULD RELATED REPORTS BE IDENTIFIED A DHR REVIEW IS NOT REQUIRED. A REVIEW OF THE MEDICAL RECORDS WAS PERFORMED AS PART OF THE PREVIOUS INVESTIGATION. PLEASE SEE THE ATTACHED ASSOCIATED COMPLAINT FOR THOSE RESULTS. PER (B)(4) A MEDICAL RECORD REVIEW IS NOT REQUIRED FOR THIS COMPLAINT RECORD. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE(S) WAS IDENTIFIED. WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.
(B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PATIENT REVISED TO ADDRESS NOISE AFTER A FALL. FOUND LINER IMPACTED AT ANGLE.
PATIENT REVISED TO ADDRESS NOISE AFTER A FALL. FOUND LINER IMPACTED AT ANGLE. UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. A FEMORAL HEAD IS NOW BEING REPORTED TO ADDRESS THESE ISSUES.
AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY SECONDARY TO FEMORAL NECK, LINER IMPINGEMENT, LINER MALPOSITION. REVISION NOTES REPORTED OF SCAR TISSUES WAS REMOVED IN ACETABULUM AND THE DISASSOCIATED THE METAL ON METAL ARTICULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE MTL INS NEUT36IDX56OD | HIP LINER | KWA | DEPUY ORTHOPAEDICS INC US | NA | 1151935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |