M2A-MAGNUM MOD HD SZ 46MM
Report
- Report Number
- 0001825034-2013-01023
- Event Type
- Injury
- Date Received
- April 17, 2013
- Report Date
- April 29, 2015
- 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
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY FURTHER PATIENT INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01023 & 2014-00724).
THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01023 & 1825034-2015-02084 & 1825034-2013-01023).
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2010. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF NEGATIVE EFFECTS TO TISSUE, BONES, MUSCLES AND LIGAMENTS, ELEVATED METAL ION LEVELS AND TISSUE AND BONE DESTRUCTION. 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF NEGATIVE EFFECTS TO TISSUE, BONES, MUSCLES AND LIGAMENTS, ELEVATED METAL ION LEVELS AND TISSUE AND BONE DESTRUCTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. AFTER REVIEWING PATIENT INVOICES, IT WAS DISCOVERED THAT THE INITIAL HIP ARTHROPLASTY ON (B)(6) 2010 WAS FOR THE LEFT HIP, NOT THE RIGHT. THE METAL ON METAL IMPLANTS STILL REMAIN IMPLANTED IN THE PATIENT'S LEFT HIP. THE DATE OF THE INITIAL RIGHT HIP ARTHROPLASTY IS UNKNOWN AS WELL AS WHAT PRODUCTS WERE IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2011. THE REASON FOR REVISION WAS POLYETHYLENE WEAR AND OSTEOLYSIS IN THE FEMORAL COMPONENT. OPERATIVE REPORT FURTHER NOTED YELLOWISH, SLIGHTLY CLOUDY FLUID, SCAR TISSUE WITH HETEROTOPIC OSSIFICATION, LEG LENGTH DISCREPANCY, CHEESE-LIKE MATERIAL THAT WAS REACTIVE TO POLYETHYLENE WEAR WITH TITANIUM METAL STAINING AND YELLOWISH AMORPHOUS MATERIAL. THE MODULAR HEAD, POLYETHYLENE ACETABULAR LINER, AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.
LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF NEGATIVE EFFECTS TO TISSUE, BONES, MUSCLES AND LIGAMENTS, ELEVATED METAL ION LEVELS AND TISSUE AND BONE DESTRUCTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. AFTER REVIEWING PATIENT INVOICES, IT WAS DISCOVERED THAT THE INITIAL HIP ARTHROPLASTY ON (B)(6) 2010 WAS FOR THE LEFT HIP. THE METAL ON METAL IMPLANTS STILL REMAIN IMPLANTED IN THE PATIENT'S LEFT HIP. THE DATE OF THE INITIAL RIGHT HIP ARTHROPLASTY IS UNKNOWN AS WELL AS WHAT PRODUCTS WERE IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2011. THE REASON FOR REVISION WAS POLYETHYLENE WEAR AND OSTEOLYSIS IN THE FEMORAL COMPONENT. OPERATIVE REPORT FURTHER NOTED YELLOWISH, SLIGHTLY CLOUDY FLUID, SCAR TISSUE WITH HETEROTOPIC OSSIFICATION, LEG LENGTH DISCREPANCY, CHEESE-LIKE MATERIAL THAT WAS REACTIVE TO POLYETHYLENE WEAR WITH TITANIUM METAL STAINING AND YELLOWISH AMORPHOUS MATERIAL. THE MODULAR HEAD, POLYETHYLENE ACETABULAR LINER, AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164994 | M2A-MAGNUM MOD HD SZ 46MM | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 789190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |