PINNACLE MTL INS NEUT36IDX54OD
Report
- Report Number
- 1818910-2011-17391
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Report Date
- July 22, 2014
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- KWA
- PMA / PMN Number
- PK083642
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Narratives
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.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
UPDATE: (B)(4) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. 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.
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 COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # PC-(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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4).
PRODUCT COMPLAINT # (B)(4).
BILATERAL PATIENT. LITIGATION PAPERS ALLEGE THE FOLLOWING: FOLLOWING HIS IMPLANTATIONS, PATIENT BEGAN EXPERIENCING DEBILITATING PAIN, DISCOMFORT, AND SORENESS IN THE AREA OF BOTH OF HIS HIP IMPLANTS, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE, AND GO UP AND DOWN STAIRS AND REQUIRES PATIENTS USAGE OF A CANE. ON INFORMATION AND BELIEF, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERIES TO REPLACE THE IMPLANTS.
SALES REP REPORTED REVISION SURGERY OF THE LINER FOR THE RIGHT HIP. REASON FOR REVISION NOT PROVIDED.
NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- BILATERAL PATIENT LITIGATION PAPERS ALLEGE THE FOLLOWING: FOLLOWING HIS IMPLANTATIONS, PATIENT BEGAN EXPERIENCING DEBILITATING PAIN, DISCOMFORT, AND SORENESS IN THE AREA OF BOTH OF HIS HIP IMPLANTS, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE, AND GO UP AND DOWN STAIRS AND REQUIRES PATIENT'S USAGE OF A CANE. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERIES TO REPLACE THE IMPLANTS. UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE REC'D (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY OF THE LINER FOR THE RIGHT HIP. REASON FOR REVISION NOT PROVIDED. SHOULD WE RECEIVE FURTHER INFORMATION, THE COMPLAINT WILL BE UPDATED AT THAT TIME. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014. UPDATE AD (B)(4) 2018: (B)(4) HAS BEEN RE-OPENED TO PC-000242880 DUE TO RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METALLOSIS,METAL WEAR, AND ELEVATED METAL IONS. UPDATED PATIENT IDENTIFIER AND CORRECTED DATE OF REVISION AND PATIENT HEIGHT. NO LABORATORY RESULTS PROVIDED. DOI: (B)(6) 2009 - DOR:07/08/2014 (RIGHT SIDE).
NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- BILATERAL PATIENT. LITIGATION PAPERS ALLEGE THE FOLLOWING: FOLLOWING HIS IMPLANTATIONS, PATIENT BEGAN EXPERIENCING DEBILITATING PAIN, DISCOMFORT, AND SORENESS IN THE AREA OF BOTH OF HIS HIP IMPLANTS, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK, MOVE, AND GO UP AND DOWN STAIRS AND REQUIRES PATIENT'S USAGE OF A CANE. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERIES TO REPLACE THE IMPLANTS. UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE REC'D (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY OF THE LINER FOR THE RIGHT HIP. REASON FOR REVISION NOT PROVIDED. SHOULD WE RECEIVE FURTHER INFORMATION, THE COMPLAINT WILL BE UPDATED AT THAT TIME. THE COMPLAINT WAS UPDATED ON:(B)(4) 2014. UPDATE AD (B)(4) 2018: (B)(4) HAS BEEN RE-OPENED TO (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METALLOSIS,METAL WEAR, AND ELEVATED METAL IONS. UPDATED PATIENT IDENTIFIER AND CORRECTED DATE OF REVISION AND PATIENT HEIGHT. NO LABORATORY RESULTS PROVIDED. DOI: (B)(6) 2009 - DOR: JUL 8, 2014 (RIGHT HIP).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE MTL INS NEUT36IDX54OD | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS | KWA | DEPUY ORTHOPAEDICS, INC. 1818910 | 2998172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |