PINNACLE MTL INS NEUT36IDX50OD
Report
- Report Number
- 1818910-2012-23689
- Event Type
- Injury
- Date Received
- October 15, 2012
- Report Date
- March 25, 2015
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KWA
- PMA / PMN Number
- PK062426
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS SIGNIFICANT DISCOMFORT, PAIN, STIFFNESS, NUMBNESS, AND LOSS OF MOTION. UPDATE REC'D 12/31/2012- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. A CORRECT DOI WAS GIVEN FOR THE LEFT HIP. AFTER REVIEW OF THE RIGHT REVISION OPERATIVE NOTE METALLOSIS WAS CONFIRMED. THE CUP ON THE RIGHT PRIMARY OPERATION WAS PREVIOUS REPORTED, BUT THE REVISION NOTE STATES IT WAS WELL FIXED AND STILL REPLACED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 6/3/2014. DOI: (B)(6) 2010 - DOR: NONE REPORTED (LEFT HIP). (B)(4) WAS A BILATERAL PATIENT. THE LEFT HIP HAS NOW BEEN TRANSFERRED TO (B)(4), WHILE THE RIGHT HIP HAS BEEN TRANSFERRED TO (B)(4). SEPTEMBER 9, 2014 UPDATED PATIENT AND PRODUCT CODES. 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 DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
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.
UPDATE: (B)(4) 2012 - THE COMPLAINT HAS BEEN REOPENED BECAUSE, IT HAS BEEN REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED ON (B)(6) 2012 TO ADDRESS PAIN. THE DATE OF IMPLANT WAS ALSO GIVEN AS (B)(6) 2010. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL PROVIDED PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE HIP LINER OR THE FEMORAL HEAD AS THE PRODUCT AND LOT CODE 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS SIGNIFICANT DISCOMFORT, PAIN, STIFFNESS, NUMBNESS, AND LOSS OF MOTION.
UPDATE 3/25/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE FROM THE RIGHT HIP INDICATED HIGH COBALT LEVELS SO THE STEM IS BEING ADDED TO THE COMPLAINT. THERE WAS NO MENTION OF METALLOSIS IN THE MEDICAL RECORDS FOR THE LEFT HIP.
UPDATE REC'D 12/31/2012- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. A CORRECT DOI WAS GIVEN FOR THE LEFT HIP. AFTER REVIEW OF THE RIGHT REVISION OPERATIVE NOTE METALLOSIS WAS CONFIRMED. THE CUP ON THE RIGHT PRIMARY OPERATION WAS PREVIOUS REPORTED, BUT THE REVISION NOTE STATES IT WAS WELL FIXED AND STILL REPLACED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE MTL INS NEUT36IDX50OD | HIP ACT. INS/LINER | KWA | DEPUY ORTHOPAEDICS INC US | 3148828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |