M2A-38 CUP NON FLARED SZ 60MM
Report
- Report Number
- 0001825034-2013-00537
- Event Type
- Injury
- Date Received
- March 8, 2013
- Date of Event
- December 26, 2014
- Report Date
- February 27, 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
- FL, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES,"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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - N/A. DATE EXPLANTED - N/A. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00537 / 00541).
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2005 AND (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, DYSFUNCTION, DISCOMFORT AND SORENESS. 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.
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2005 AND (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, DYSFUNCTION, DISCOMFORT, AND SORENESS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTS THE SIDE IMPLANTED (B)(6) 2007 WAS REVISED (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED ION LEVELS. THE CUP WAS REMOVED AND REPLACED. TO DATE, THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE SIDE IMPLANTED (B)(6) 2005.
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2005 AND (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, DYSFUNCTION, DISCOMFORT, AND SORENESS. ADDITIONAL INFORMATION RECEIVED REPORTS THE RIGHT SIDE IMPLANTED (B)(6) 2007 WAS REVISED (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED ION LEVELS. THE CUP WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTS THE LEFT SIDE IMPLANTED (B)(6) 2005 WAS REVISED (B)(6) 2014 DUE TO PAIN AND ELEVATED CHROMIUM LEVEL. THE CUP AND HEAD 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 REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2014 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF A CHRONIC-APPEARING TROCHANTERIC BURSA, DEBRIS, TRUNNION CORROSION, CAVITARY DEFECTS IN THE ACETABULUM AND NO SIGNS OF METALLOSIS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF CHRONIC TROCHANTERIC BURSITIS, FLUID, AND CHRONIC INFLAMMATION. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED.
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2005 AND (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, DYSFUNCTION, DISCOMFORT, AND SORENESS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTS THE RIGHT SIDE IMPLANTED (B)(6) 2007 WAS REVISED (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED ION LEVELS. THE CUP WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTS THE LEFT SIDE IMPLANTED (B)(6) 2005 WAS REVISED (B)(6) 2014. IT WAS REPORTED THAT DURING THE REVISION PROCEDURE THE CUP WAS ALLEGEDLY NOTED TO BE WELL FIXED WITH NO OBVIOUS BONE DETERIORATION. THE CUP AND HEAD WERE REMOVED AND REPLACED.
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2005 AND (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, DYSFUNCTION, DISCOMFORT, AND SORENESS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTS THE RIGHT SIDE IMPLANTED (B)(6) 2007 WAS REVISED (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED ION LEVELS. THE CUP WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTS THE LEFT SIDE IMPLANTED (B)(6) 2005 WAS REVISED (B)(6) 2014 DUE TO PAIN AND ELEVATED CHROMIUM LEVEL. THE CUP AND HEAD WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99844 | M2A-38 CUP NON FLARED SZ 60MM | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 767610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |