PINNACLE MTL INS NEUT28IDX48OD
Report
- Report Number
- 1818910-2011-08243
- Event Type
- Injury
- Date Received
- May 12, 2011
- Date of Event
- May 25, 2009
- Report Date
- April 12, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KWA
- PMA / PMN Number
- K002883
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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
ADDITIONAL INFO: D1, D2, D3, D4: CATALOG AND LOT #, F7, F10, G4, G5, H2, H4. UPDATE:12/26/2012- PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. IT WAS NOTED IN THE PRIMARY SURGERY THAT A SLIGHT CRACK WAS NOTED IN THE PROXIMAL FEMUR. THE REVISION OPERATIVE NOTES STATE THE PATIENT WAS REVISED DUE TO FAILED FEMORAL COMPONENTS WITH LOOSENING OF THE HIP PROSTHESIS. THE STEM AND SLEEVE WERE ADDED TO THE COMPLAINT. ALSO NOTED ON (B)(6) 2009, PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
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: A2 (DOB), D2B (PROCODE/REGSTAT), D4 (UDI), G3, G5 (PMA/510K), H4, H6 (PATIENT CODE) AND H10.
PRODUCT COMPLAINT # ==> (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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: 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. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE HISTORY LOT ==> NULL. DEVICE HISTORY BATCH ==> NULL. DEVICE HISTORY REVIEW ==> NULL.
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 BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY AS NOT 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 (DEVICE). 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.
PPF ALLEGES DISLOCATION AND LOOSENING OF STEM. ADDED DOB, LAWYER, REVISION SURGEON IN ASSOCIATED CONTACT, ACCOUNT NAME, PATIENT HARM AND MANUFACTURED DATE IN IPS. DOI: (B)(6) 2004 - DOR: (B)(6) 2009 (RIGHT HIP).
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 AND ARE PRESUMED YET IMPLANTED. 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.
LITIGATION PAPERS ALLEGE: PATIENT'S HIP BEGAN TO NOTICE INCREASING PAIN AND DISCOMFORT IN HER HIP. BY 2008, THE PAIN AND DISCOMFORT MADE IT DIFFICULT FOR PATIENT TO WALK. HER [PHYSICIAN] DECIDED THAT PATIENT NEEDED TO HAVE HER HIP IMPLANT SURGICALLY REMOVED AND REPLACED AS SOON AS POSSIBLE. OVER THE NEXT TWO MONTHS, PATIENT'S HIP DISLOCATED TWICE. ON (B)(6) 2009 PATIENT UNDERWENT YET ANOTHER SURGICAL PROCEDURE TO REDUCE HER HIP BACK INTO THE JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541354 | PINNACLE MTL INS NEUT28IDX48OD | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS | KWA | DEPUY ORTHOPAEDICS INC US | NA | 1119031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female | Required Intervention |