M2A-MAGNUM PF CUP 52ODX46ID
Report
- Report Number
- 0001825034-2013-01263
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- February 26, 2013
- Report Date
- August 5, 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
- WI, US
- Reporter Occupation
- PHYSICIAN
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: INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00741-1 AND 01263/ 01264).
THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT 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: ¿¿MATERIAL SENSITIVITY REACTIONS.¿ AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00741/-01263/-01264/-04778).
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 2 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00741, 01263/01264 & 04778).
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY (B)(6) 2013 DUE TO ALLEGED PAIN AND ELEVATED METAL ION LEVELS. ACETABULAR CUP AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY (B)(6), 2013 DUE TO ALLEGED PAIN AND ELEVATED METAL ION LEVELS. ACETABULAR CUP AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT INITIAL HIP ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, A REVISION OCCURRED ON (B)(6), 2013 DUE TO UNKNOWN REASONS. REPORT FURTHER ALLEGES THERE WAS NO EVIDENCE OF ELEVATED METAL ION LEVELS. THE HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METAL POISONING, AND METALLOSIS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY (B)(6) 2013 DUE TO ALLEGED PAIN AND ELEVATED METAL ION LEVELS. ACETABULAR CUP AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT INITIAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A REVISION OCCURRED ON (B)(6) 2013 DUE TO UNKNOWN REASONS. REPORT FURTHER ALLEGES THERE WAS NO EVIDENCE OF ELEVATED METAL ION LEVELS. THE HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METAL POISONING, AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2013 RIGHT HIP REVISION OPERATIVE REPORT NOTED THE REVISION WAS DUE TO PAIN, ELEVATED METAL ION LEVELS, AND INCREASED ABDUCTION OF THE ACETABULAR COMPONENT. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF SCAR TISSUE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY (B)(6) 2013 DUE TO ALLEGED PAIN AND ELEVATED METAL ION LEVELS. ACETABULAR CUP AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT INITIAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A REVISION OCCURRED ON (B)(6) 2013 DUE TO UNKNOWN REASONS. REPORT FURTHER ALLEGES THERE WAS NO EVIDENCE OF ELEVATED METAL ION LEVELS. THE HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METAL POISONING, AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2013 RIGHT HIP REVISION OPERATIVE REPORT NOTED THE REVISION WAS DUE TO PAIN, ELEVATED METAL ION LEVELS, AND INCREASED ABDUCTION OF THE ACETABULAR COMPONENT. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF SCAR TISSUE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT LEFT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED SCAR TISSUE AND OSTEOPHYTE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194966 | M2A-MAGNUM PF CUP 52ODX46ID | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 213020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |