M2A-MAGNUM MOD HEAD SZ 52MM

Report

Report Number: 0001825034-2014-04838
Event Type: Injury
Date Received: May 27, 2014
Date of Event: July 16, 2014
Report Date: December 28, 2017
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: AL, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04837 / 04838).

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: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES."

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

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. THIS REPORT IS NUMBER 2 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04837 / 04838 & 2015-00904).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 139264, M2A-MAGNUM 52-60MM TPR INSRT-6, LOT 540900; 11-104209, MLRY-HD LAT POR FMRL 9MM, LOT 456690; US157858, M2A-MAGNUM PF CUP 58ODX52ID, LOT 783640. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES. THE CUP WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. DUE TO FOREIGN MATERIAL BOTH THE INSIDE AND OUTSIDE OF THE DEVICE, MEASUREMENTS COULD BE TAKEN TO EVALUATE THE COMPLAINT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND FROM REVISION OP NOTES: OSTEOLYSIS WAS NOTED. FIBRINOUS MATERIAL, VILLOUS TENOSYNOVITIS WAS PRESENT WHEN THE HIP WAS ENTERED WHICH WERE SENT FOR CULTURE, HISTOLOGIC EXAMINATION. THE FEMORAL HEAD WAS STILL VERY WELL FIXED. THE DISC REMAINED COLD WELDED TO THE TITANIUM COMPONENT. WITH THE REMOVAL OF ACETABULAR COMPONENT, FIBROUS MEMBRANE IN COTYLOID NOTCH WAS DEBRIDED AND A CYSTIC AREA WITH SUPERMEDIAL CYST WAS ENCOUNTERED WITH LOSS OF CANCELLUS BONE. DISLOCATION WAS NOT MENTIONED AS DESCRIBED IN COMPLAINT DESCRIPTION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

Description of Event or Problem · 1

LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DISLOCATION, AND LACK OF MOBILITY. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL ARTHROPLASTY DATE OF (B)(6) 2006. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED

Description of Event or Problem · 1

LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DISLOCATION, AND LACK OF MOBILITY. ALL COMPONENTS WERE REMOVED AND REPLACED. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL ARTHROPLASTY DATE OF (B)(6) 2006. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED

Description of Event or Problem · 1

LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DISLOCATION, AND LACK OF MOBILITY. ALL COMPONENTS WERE REMOVED AND REPLACED. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL ARTHROPLASTY DATE OF (B)(6) 2006. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED ADDITIONAL INFORMATION RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2014 DUE TO PAIN. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF OSTEOPHYTIC BONE, FIBRINOUS MATERIAL, VILLOUS TENOSYNOVITIS, A CYSTIC AREA WITH A SUPEROMEDIAL CYST, AND THE TAPER ADAPTER WAS COLD-WELDED ONTO THE STEM. ALL COMPONENTS WERE REMOVED AND REPLACED.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT HAD A REVISION PROCEDURE EIGHT YEARS POST-IMPLANTATION DUE TO PAIN. OPERATIVE REPORT FURTHER NOTES THE PRESENCE OF OSTEOPHYTIC BONE, FIBRINOUS MATERIAL, VILLOUS TENOSYNOVITIS, AND A CYSTIC AREA WITH A SUPEROMEDIAL CYST. ALL COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
311468	M2A-MAGNUM MOD HEAD SZ 52MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	168470

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Hospitalization\| R