PROFEMUR® PRESERVE CLASSIC

MDR report key: 15743867 · Received November 7, 2022

Report

Report Number: 3010536692-2022-00398
Event Type: Injury
Date Received: November 7, 2022
Date of Event: September 23, 2022
Report Date: December 21, 2022
Manufacturer: MICROPORT ORTHOPEDICS INC.
Product Code: LZO
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem · 0

ALLEGEDLY, PERIPROSTHETIC FEMORAL STEM FRACTURE OCCURRED DURING REHABILITATION A FEW WEEKS AFTER OP ON (B)(6). PHYSICIAN'S FINDING: THE FRACTURE WAS CAUSED BY A LONGITUDINAL SPLIT FRACTURE ON THE LATERAL SIDE OF THE FEMUR, WHICH MAY HAVE BEEN CAUSED BY STRESS ON THE LATERAL SIDE WHEN A LOAD WAS APPLIED. THIS WAS THE INITIAL FINDING. REPORTING PHYSICIAN'S FINDINGS AND RESPONSE STATUS: WHEN THE FEMUR WAS RASPED IN THE SUPER PATH, A CRACK MAY HAVE ALREADY BEEN IN THE FEMUR. WHEN APPROACHING WITH THE SUPER PATH, THE APPROACH TENDS TO BE VERTICAL OR SLIGHTLY LATERAL IN DIRECTION. ALSO, DUE TO THE STEM SHAPE CHARACTERISTIC OF THE PRESERVE STEM, WHEN THE STEM IS STRAIGHT OR OUTWARDLY BENT, IT IS LIKELY THAT A LARGE SIZE IS INSERTED OR STRESS IS APPLIED TO THE OUTER SIDE OF THE STEM. PRODUCTS NO REVISED: PRODUCT ID: PHA04412, LOT: 1900043, QTY: 1, PRODUCT ID: P3SBMC50, LOT: 1874728, QTY: 1, PRODUCT ID: P2LELC32, LOT: 1854672, QTY: 1, PRODUCT ID: MSTCBM20, LOT: 1917612, QTY: 1. JAPAN-(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2852930	PROFEMUR® PRESERVE CLASSIC	HIP COMPONENT	LZO	MICROPORT ORTHOPEDICS INC.	PPRCLS04	1856921

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention