FDA Adverse Event Injury Summary report: N

BIOLOX DELTA CER LNR 40MM G

MDR report key: 25000803 · Received April 27, 2026

Report

Report Number: 3002806535-2026-00166
Event Type: Injury
Date Received: April 27, 2026
Date of Event: March 30, 2026
Report Date: April 27, 2026
Manufacturer: BIOMET UK LTD.
Product Code: LZO
UDI-DI: 05019279494767
PMA / PMN Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

(B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024519848. D10 - ASSOCIATED MEDICAL DEVICES: G7 OSSEOTI 4 HOLE SHELL 60MM G; ITEM# 110010248; LOT# 65862932. G2 - FOREIGN: EVENT OCCURRED IN AUSTRALIA. G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PAIN. THE PATIENT WAS FOUND TO BE 9 MM LONG AND THE CUP ORIENTATION WAS APPROXIMATELY 38 DEG INCLINATION AND 15 DEG ANTEVERSION. THE SURGEON INCREASED THE OFFSET TO NORMAL HIP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
206196	BIOLOX DELTA CER LNR 40MM G	PROSTHESIS, HIP	LZO	BIOMET UK LTD.		3881827	05019279494767

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR	Unknown	Required Intervention\| H	SEE H11 NARRATIVE.