FDA Adverse Event Injury Summary report: N

M2A 38MM MODULAR HEAD STD NK

MDR report key: 2810080 · Received October 31, 2012

Report

Report Number: 0001825034-2012-02180
Event Type: Injury
Date Received: October 31, 2012
Report Date: October 1, 2012
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK011110
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

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. 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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02180 & 1825034-2012-02305).

Description of Event or Problem · 1

LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS RIGHT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2002 AND A LEFT HIP ARTHROPLASTY TOOK PLACE ON (B)(6) 2004. THERE HAVE BEEN NO REPORTED REVISION PROCEDURES. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	M2A 38MM MODULAR HEAD STD NK	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	403540

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R