M2A-MAGNUM PF CUP 56ODX50ID
Report
- Report Number
- 0001825034-2014-03998
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- October 20, 2014
- Report Date
- December 12, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PK042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03995 / 03998). THIS REPORT IS BEING SUBMITTED ONE DAY LATE DUE TO ESG DOWNTIME ON (B)(6) 2014.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED DATA: RELEVANT TEST - DATE OF LABS.
THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL.
LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, TROUBLE WALKING, DIFFICULTY SITTING/STANDING/TAKING STAIRS AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL FOR PATIENT ALLEGED THAT A RIGHT HIP REVISION PROCEDURE WAS PLANNED FOR (B)(6) 2014. THERE WAS NO REPORTED REVISION PROCEDURE FOR THE LEFT HIP. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATES. FURTHER FOLLOW UP CONFIRMED THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2014 AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT 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 PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON MAY 24, 2010 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, TROUBLE WALKING, DIFFICULTY SITTING/STANDING/TAKING STAIRS AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL FOR PATIENT ALLEGED THAT A RIGHT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2014. THERE WAS NO REPORTED REVISION PROCEDURE FOR THE LEFT HIP. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATES. FURTHER FOLLOW UP CONFIRMED THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2014 AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF SCAR TISSUE AND THAT ALL COMPONENTS WERE WELL FIXED WITH NO EVIDENCE OF PSUEDOTUMORS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTS PATIENT WAS REVISED (B)(6) 2014 ON THE LEFT SIDE DUE TO PAIN. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED.
LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, TROUBLE WALKING, DIFFICULTY SITTING/STANDING/TAKING STAIRS AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL FOR PATIENT ALLEGED THAT A RIGHT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2014. THERE WAS NO REPORTED REVISION PROCEDURE FOR THE LEFT HIP. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATES. FURTHER FOLLOW UP CONFIRMED THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2014 AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF SCAR TISSUE AND THAT ALL COMPONENTS WERE WELL FIXED WITH NO EVIDENCE OF PSEUDOTUMORS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTS PATIENT WAS REVISED (B)(6) 2014 ON THE LEFT SIDE DUE TO PAIN. THE MODULAR HEAD, TAPER ADAPTER 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 LEFT HIP REVISION ON (B)(6) 2014 WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED SCAR TISSUE, AND A BROWNISH DISCOLORATION OF THE SYNOVIUM AND SYNOVITIS.
LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, TROUBLE WALKING, DIFFICULTY SITTING/STANDING/TAKING STAIRS AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL FOR PATIENT ALLEGED THAT A RIGHT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2014. THERE WAS NO REPORTED REVISION PROCEDURE FOR THE LEFT HIP. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATES. FURTHER FOLLOW UP CONFIRMED THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2014 AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF SCAR TISSUE AND THAT ALL COMPONENTS WERE WELL FIXED WITH NO EVIDENCE OF PSEUDOTUMORS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290112 | M2A-MAGNUM PF CUP 56ODX50ID | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 520080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R |