M2A-MAGNUM MODULAR HEAD SZ 50MM

Report

Report Number: 0001825034-2013-01687
Event Type: Injury
Date Received: May 29, 2013
Date of Event: May 6, 2013
Report Date: September 30, 2016
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: WV, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED DUE TO PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

Additional Manufacturer Narrative · 1

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: "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "MATERIAL SENSITIVITY REACTIONS.¿ 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 1 OF 4 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2014-04063/-04064/-04065).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). THIS REPORT IS NUMBER 1 OF 6 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01687, 2014-04063 / 04065, 2015-00532 AND 2016-04310).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 5 MDR'S FILED FOR THE SAME PERSON (REFERENCE 1825034-2013-01687 & 2014-04063 / 04065 & 2015-00532).

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL DOCUMENT FURTHER ALLEGES A RIGHT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS.

Description of Event or Problem · 1

PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE NOTES REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN, METALLIC STAINED TISSUE, METAL CORROSION AT THE TAPER AND BROWNISH TISSUE CONSISTENT WITH METALLOSIS AROUND THE ACETABULUM. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A COMPETITOR CUP AND BIOMET HEAD AND TAPER ADAPTER.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL DOCUMENT FURTHER ALLEGES A RIGHT HIP REVISION OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE REPORT NOTED PRESENCE OF CLEAR SEROUS FLUID, METALLIC STAINED TISSUE, METAL CORROSION AT THE TAPER AND BROWNISH TISSUE CONSISTENT WITH METALLOSIS AROUND THE ACETABULUM. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A COMPETITOR CUP AND BIOMET HEAD AND TAPER ADAPTER. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
237558	M2A-MAGNUM MODULAR HEAD SZ 50MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	524520

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Hospitalization\| R