FREEDOM ALL POLY CUP 50MM
Report
- Report Number
- 0001825034-2012-02279
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- January 9, 2012
- Report Date
- November 25, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWZ
- PMA / PMN Number
- PK030047
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTION INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY." NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." NUMBER 15 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-02062-1, 02278-1/02279-1 & 2013-02227).
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 5 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02062, 02278 / 02279, 2013-02227 AND 2014-08958).
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. INFORMATION RECEIVED ON THE REVISION INVOICE INDICATES THE MODULAR HEAD WAS REPLACED. IT IS NOT KNOWN IF THE REVISION WAS PERFORMED ON THE RIGHT HIP OR THE LEFT HIP. REVIEW OF DEVICE HISTORY RECORDS FOR BOTH MODULAR HEADS IN THE RIGHT AND LEFT HIPS SHOW THAT BOTH LOTS RELEASED WITH NO RECORDED ANOMALY. THE FOLLOWING WERE NOT COMPLETED AS THE MODULAR HEAD COMPONENT COULD HAVE BEEN FROM THE RIGHT OR LEFT HIP PROCEDURES; THEREFORE, THE INFORMATION BELOW REFLECTS DETAILS FOR BOTH COMPONENTS. CATALOGUE NUMBER: LEFT - 11-107018; RIGHT - 11-107016. LOT NUMBER: LEFT - 515980; RIGHT - 527320. EXPIRY DATE: LEFT - 4/30/17; RIGHT - 11/30/20. DATE IMPLANTED: LEFT - (B)(6) 2007; RIGHT - (B)(6) 2011. MANUFACTURE DATE: LEFT 4/27/07; RIGHT - 11/4/10. THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02062, 1825034-2012-02278 / 02279).
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6), 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2009. A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2007 AND A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2011. ANOTHER REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012 ON THE RIGHT HIP. THE REASON FOR THE REVISION PROCEDURES WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE RIGHT HIP REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO ACETABULAR CUP LOOSENING, OSTEOLYSIS AND PAIN. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THE LEFT HIP REVISION THAT TOOK PLACE ON (B)(6) 2006 WAS DUE TO DISLOCATION. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE PREVIOUSLY REPORTED RIGHT HIP REVISION ON (B)(6) 2011 WAS A LEFT HIP REVISION AND WAS DUE TO DISLODGEMENT OF THE ACETABULAR COMPONENT. THE PATIENT'S OPERATIVE REPORT NOTED A LOOSE ACETABULAR COMPONENT, TWO BROKEN SCREWS, AND FIBROUS TISSUE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED A STAGE 1 LEFT HIP REVISION ON (B)(6) 2007 DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED EVIDENCE OF REACTIVE SYNOVIUM, NO INGROWTH BEHIND THE ACETABULAR COMPONENT, AND PERIPROSTHETIC INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S PROSTALAC COMPONENTS. FURTHER INFORMATION IN PATIENT MEDICAL RECORDS REVEALED A STAGE 2 LEFT HIP REVISION ON (B)(6) 2007 DUE TO THE TREATMENT OF THE INFECTION WITH RE-IMPLANTATION OF BIOMET COMPONENTS.
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2009. A LEFT HIP REVISION WAS PERFORMED ON (B)(6), 2007 AND A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2011. ANOTHER REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012 ON THE RIGHT HIP. THE REASON FOR THE REVISION PROCEDURES WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE RIGHT HIP REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO ACETABULAR CUP LOOSENING, OSTEOLYSIS AND PAIN. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THE LEFT HIP REVISION THAT TOOK PLACE ON (B)(6) 2006 WAS DUE TO DISLOCATION. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2009. A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2007 AND A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2011. ANOTHER REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012, BUT IT IS NOT KNOWN WHETHER IT WAS FOR THE LEFT OR RIGHT HIP. THE REASON FOR THE REVISION PROCEDURES WAS NOT REPORTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEDOM ALL POLY CUP 50MM | PROSTHESIS, HIP | KWZ | BIOMET ORTHOPEDICS | N/A | 059690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R |