M2A 38MM MODULAR HEAD STD NK
Report
- Report Number
- 0001825034-2012-02133
- Event Type
- Injury
- Date Received
- October 25, 2012
- Date of Event
- February 1, 2012
- Report Date
- January 20, 2015
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PK011110
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: THE REPORT THAT "PATIENT UNDERWENT A REVISION ON THE LEFT HIP ON (B)(6) 2012," WAS MADE IN ERROR AND HAS BEEN CORRECTED IN THIS REPORT. THIS REPORT IS NUMBER 2 OF 6 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02132-1/-02133-1 & -2013-02262 / -02264 & -2015-00410).
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE DATE OF THE REVISION AND THE REASON FOR THE REVISION PROCEDURE, 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." 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 2 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02132-1/02133-1 & 2013-02262 / 02264).
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. THE FOLLOWING SECTION COULD NOT BE COMPLETED WITH THE INFORMATION PROVIDED. DATE EXPLANTED - A REVISION PROCEDURE OCCURRED ON (B)(6) 2012; HOWEVER, IT IS NOT KNOWN WHICH HIP WAS REVISED. THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02132 / 02133).
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS PATIENT UNDERWENT LEFT HIP ARTHROPLASTY ON (B)(6) 2003 AND RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. FURTHER, INVOICE HISTORY REVEALED A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012; HOWEVER, IT IS NOT KNOWN WHICH HIP WAS REVISED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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 REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS PATIENT UNDERWENT LEFT HIP ARTHROPLASTY ON (B)(6) 2003 AND RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS FOR THE RIGHT HIP AND DUE TO PAIN AND METAL ON METAL HYPERSENSITIVITY. THE OPERATIVE (OP) NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT HIP ON (B)(6) 2012 DUE TO INFECTION. THE OPERATIVE NOTES CONFIRM THE MODULAR HEAD AND LINER 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 OPERATIVE (OP) REPORT DATED (B)(6) 2012 NOTES THE PRESENCE OF FIBRINOUS MATERIAL AND REACTIVE TISSUE. OP REPORT DATED (B)(6) 2012 NOTES PURULENT FLUID, DEVITALIZED TISSUE, LITTLE EVIDENCE OF HEALING AROUND THE CAPSULAR TEAR, AND EVIDENCE THAT THE SUTURES HAD BEEN PULLED OUT FROM THE CAPSULE. ADDITIONAL OP NOTES DATED (B)(6) 2012 AND (B)(6) 2013 REPORT A 2-STAGE REVISION DUE TO INFECTION. ALL COMPONENTS WERE REMOVED (B)(6) 2012 AND REPLACED (B)(6) 2013. FLUID WAS NOTED DURING BOTH PROCEDURES. SUBSEQUENTLY, OP REPORT DATED (B)(6) 2013 REPORTS A REVISION PROCEDURE DUE TO PAIN AND A LOOSE RIGHT FEMORAL COMPONENT WITH SUBSIDENCE. PATIENT MEDICAL RECORDS REPORT ALL REVISION PROCEDURES ARE FOR THE RIGHT HIP. THERE HAVE BEEN NO MEDICAL RECORDS RECEIVED, TO DATE, TO INDICATE A LEFT REVISION PROCEDURE HAS OCCURRED.
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS PATIENT UNDERWENT LEFT HIP ARTHROPLASTY ON (B)(6) 2003 AND RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. FURTHER, INVOICE HISTORY REVEALED A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012; HOWEVER, IT IS NOT KNOWN WHICH HIP WAS REVISED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS FOR THE RIGHT HIP AND DUE TO PAIN AND METAL ON METAL HYPERSENSITIVITY. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT HIP ON (B)(6) 2012 DUE TO INFECTION. THE OPERATIVE NOTES CONFIRM THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. PATIENT UNDERWENT A REVISION ON THE LEFT HIP ON (B)(6) 2012 AND A THIRD REVISION OF THE RIGHT HIP ON (B)(6) 2013 DUE TO UNKNOWN REASONS. 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 | M2A 38MM MODULAR HEAD STD NK | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 472830 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| R |