FDA Adverse Event Malfunction Summary report: N

ENDURO MENISCAL COMPONENT F2 10MM

MDR report key: 4436278 · Received January 14, 2015

Report

Report Number: 3005673311-2015-00005
Event Type: Malfunction
Date Received: January 14, 2015
Report Date: January 14, 2015
Manufacturer: AESCULAP AG AND CO. KG
Product Code: KRO
PMA / PMN Number: K101815
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PMA/510 (K) #: K101815/K120955. US REPORTING AGENT NOTIFIED ON (B)(4) 2015. MFG SITE EVAL: ENDURO COMPONENT WAS FOUND TO BE FRACTURED BELOW THE CONE. THE FRAGMENT WITH THE CONE IS FIXED FIRMLY IN THE FEMUR COMPONENT AND THEREFORE, THE FEMUR COMPONENT HAS TO BE REMOVED. THE MFG DOCUMENTS OF ALL INVOLVED COMPONENTS WERE CHECKED AND ALL WERE FOUND TO BE FREE OF ANY DEVIATIONS. THE FRACTURE SURFACE EXHIBITS A FATIGUE FRACTURE WHICH INITIATED THE POSTERIOR (POSTERO-LATERAL) SIDE AND PROTRUDED ANTERIORLY (ANTERO-MEDIAL). FROM THE MARKINGS ON THE FEMUR COMPONENT, IT CAN BE SEEN THAT THE PT WAS EXERTING A HIGH MOMENT TOWARD HYPEREXTENSION. THIS MOST LIKELY CAUSED THE CRACK INITIATION ON THE POSTERO-LATERAL EDGE OF THE ROTATION AXIS.

Description of Event or Problem · 1

COUNTRY OF COMPLAINT: (B)(6). THE PT HAS A POLYNEUROPATHY. AFTER THE SURGERY, THE PT WAS APPARENTLY ONLY MOBILE WITH WALKING AIDS. ON (B)(6) 2014, THE PT WENT TO DR WITH ACUTE INSTABILITY. HE NOTED METALLIC NOISES. A REVISION WAS CARRIED-OUT AND THE AXIS WAS FOUND TO BE BROKEN. INVOLVED COMPONENTS: NB018K LOT # 51800517/ ENDURO FEMORAL COMPONENT CEMENTED F2R. NR410K LOT # 51774154/ FEMUR EXTENS. STEM 5 DEGREE D20X117MM CEM.LESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
34307	ENDURO MENISCAL COMPONENT F2 10MM	KNEE PROTHESIS	KRO	AESCULAP AG AND CO. KG	NR880M	51791495

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other