PINNACLE MTL INS NEUT36IDX54OD
Report
- Report Number
- 1818910-2011-15454
- Event Type
- Injury
- Date Received
- August 12, 2011
- Report Date
- July 11, 2011
- Manufacturer
- DEPUY ORTHOPAEDIC INC, 1818910
- Product Code
- KWA
- PMA / PMN Number
- K003523
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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.
THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.
LITIGATION PAPERS ALLEGE THE PATIENT CONTINUES TO SUFFER FROM PERSISTENT PAIN. ADDITIONALLY IT IS ALLEGED THE PATIENT INTENDS TO UNDERGO REVISION SURGERY TO REMOVE HIS DEVICES AND REPLACE THEM WITH NEW HIP IMPLANT SYSTEMS, IF INDICATED BY HIS DOCTOR. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP). DOI: (B)(6) 2009 - DOR: NONE REPORTED (RIGHT 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.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(4).
LITIGATION PAPERS ALLEGE THE PT CONTINUES TO SUFFER FROM PERSISTENT PAIN. ADDITIONALLY, IT IS ALLEGED THE PT INTENDS TO UNDERGO SURGERY TO REMOVE HIS DEVICES AND REPLACE THEM WITH NEW HIP IMPLANT SYSTEMS, IF INDICATED BY HIS DOCTOR.
LITIGATION PAPERS ALLEGE THE PATIENT CONTINUES TO SUFFER FROM PERSISTENT PAIN. ADDITIONALLY IT IS ALLEGED THE PATIENT INTENDS TO UNDERGO REVISION SURGERY TO REMOVE HIS DEVICES AND REPLACE THEM WITH NEW HIP IMPLANT SYSTEMS, IF INDICATED BY HIS DOCTOR. *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.
NEW UNITY RECORD CREATED IN ORDER TO UPDATE ETQ COMPLAINT NUMBER (B)(4). NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: LITIGATION PAPERS ALLEGE THE PATIENT CONTINUES TO SUFFER FROM PERSISTENT PAIN. ADDITIONALLY IT IS ALLEGED THE PATIENT INTENDS TO UNDERGO REVISION SURGERY TO REMOVE HIS DEVICES AND REPLACE THEM WITH NEW HIP IMPLANT SYSTEMS, IF INDICATED BY HIS DOCTOR. 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 AD (B)(4) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECEIVED. THERE IS NO NEW ALLEGATION AND REVISION REPORTED. ADDED LAWYER AND LAW FIRM. DOI: (B)(6) 2008 - DOR: NOT REPORTED (LEFT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR RIGHT HIP.
NEW UNITY RECORD CREATED IN ORDER TO UPDATE ETQ COMPLAINT NUMBER (B)(4). NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: LITIGATION PAPERS ALLEGE THE PATIENT CONTINUES TO SUFFER FROM PERSISTENT PAIN. ADDITIONALLY IT IS ALLEGED THE PATIENT INTENDS TO UNDERGO REVISION SURGERY TO REMOVE HIS DEVICES AND REPLACE THEM WITH NEW HIP IMPLANT SYSTEMS, IF INDICATED BY HIS DOCTOR. 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 AD (B)(4) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECEIVED. THERE IS NO NEW ALLEGATION AND REVISION REPORTED. ADDED LAWYER AND LAW FIRM. DOI: (B)(6) 2008 - DOR: NOT REPORTED (LEFT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR 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 ORTHOPAEDIC INC, 1818910 | NA | 2786848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |