M2A MAGNUM MODULAR HEAD 52MM HEAD DIAMETER
Report
- Report Number
- 0001825034-2016-04755
- Event Type
- Injury
- Date Received
- November 18, 2016
- Report Date
- December 15, 2020
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PK042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D10, G4, H2, H3 ONE M2A-MAGNUM MOD HD SZ 52MM WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE RETURNED DEVICE HAD SCUFFING ON THE OUTSIDE RADIUS AND THERE WAS A DISCOLORATION LINE INSIDE OF THE TAPER HOLE. ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS/RADIOGRAPHS S IDENTIFIED THE FOLLOWING: PAIN, SQUEAKING, INCREASED METAL LEVELS FLUID WAS CULTURED. FLUID HAD TYPICAL CLOUDY BUT NOT PURULENT APPEARANCE OF METALLOSIS. SCARRED EXTERNAL ROTATOR WAS TAKEN OFF THE TROCHANTER. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4).
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS: PN: 11-103204, LN: 925870, TAPERLOC POR FMRL LAT. PN: US157858, LN: 043360, M2A-MAGNUM PF CUP 58OD. PN: 139264, LN: 004100, M2A-MAGNUM 52-60MM TPR. THERAPY DATE - (B)(6) 2015.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
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 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." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EVENT DATE: (B)(6) 2015. EXPLANT DATE: (B)(6) 2015. 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 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04754 / 04755).
LEGAL COUNSEL FOR PATIENT REPORTED RIGHT HIP REVISION APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN, TISSUE DESTRUCTION, BONE DESTRUCTION, METAL WEAR, METAL POISONING, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVIEW OF INVOICE HISTORY SHOWS THE MODULAR HEAD WAS REMOVED AND REPLACED AND A POLY BEARING WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763954 | M2A MAGNUM MODULAR HEAD 52MM HEAD DIAMETER | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 154530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |