InjuryNPJ

UNKNOWN STRYKER MCK 6X10 INSERT

Received Apr 24, 2026 · Event occurred Mar 30, 2026

Report 3005985723-2026-00192 · MDR key 24979516

Device

Generic name

Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polym

Manufacturer

Mako Surgical Corp.

Catalog number

UNK_OFL

Lot number

UNKNOWN

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

68 YR · Male

Unspecified Infection

Narrative

Additional Manufacturer Narrative

THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT#;DEVICE NAME; LOT#: UNK_OFL; UNKNOWN STRYKER MCK 6LM FEMUR; UNKNOWN. UNK_OFL; UNKNOWN STRYKER MCK 6LM TIBIAL BASEPLATE; UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A LEFT MAKO MEDIAL UNI DUE TO INFECTION. HE REVISED TO A PRIMARY TRIATHLON.