FDA Adverse Event Injury Summary report: N

REJUVAKNEE

MDR report key: 24066012 · Received January 14, 2026

Report

Report Number
2249852-2026-00003
Event Type
Injury
Date Received
January 14, 2026
Date of Event
November 21, 2025
Report Date
January 14, 2026
Manufacturer
COLLAGEN MATRIX, INC.
Product Code
OLC
UDI-DI
00813954026022
PMA / PMN Number
K242302
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

A COMPLAINT WAS RECEIVED ON A COLLAGEN MENISCUS MEMBRANE. AT 4 MONTH MRI FINDING, THE COMPLAINT INDICATED "GRAFT MATERIAL IS NOT WELL APPRECIATED AT THE MENISCUS AND IS THOUGHT TO BE PRESENTLY DISPLACED TO THE ANTERIOR COMPARTMENT. NOT DEFINITIVE. MEDIAL MENISCUS IS PERIPHERALLY SUBLUXED WITH SOME REACTIVE MEDICAL MENISCAL CAPSULAR INFLAMMATION." SURGERY DATE WAS (B)(6) 2025. 47-YEAR-OLD MALE WITH PRIOR RIGHT MEDIAL MENISCECTOMY IN (B)(6) 2025, WHO HAD CONTINUED SYMPTOMS AFTER. SUBSEQUENT MRI SHOWED RESIDUAL TEAR AND MEDIAL MENISCUS DEFICIENCY. HE UNDERWENT IMPLANTATION OF (B)(6) ON (B)(6) 2025. HE WAS DOING WELL AND PROGRESSING WELL WITH WEIGHTBEARING AND THERAPY. THERE WERE NO SIGNS OF INFECTION PRESENT. MILD TO MODERATE EFFUSION WAS PRESENT, WHICH IS TO BE EXPECTED POST IMPLANT. THEN ON (B)(6) 2025, HE REPORTS WALKING THROUGH THIS HOME AND FEELING TWO LOUD POPS IN THE KNEE AND EXPERIENCING SOME DISCOMFORT THAT RESOLVED IN THAT MOMENT. HOWEVER, TWO DAYS LATER HE STATES HE WAS UNABLE TO FULLY EXTEND THE KNEE. HE WENT TO THERAPY AND WAS ADVISED TO COME IN FOR EVALUATION. HE WAS SEEN FOR FOLLOW UP ON (B)(6) 2025. AN MRI WAS OBTAINED. MRI WAS READ AS "SUSPECTED GRAFT MATERIAL IS THOUGHT TO BE DISPLACED INTO THE ANTERIOR COMPARTMENT JUST ANTERIOR TO THE INTERCONDYLAR NOTCH". PATIENT HAD A SUBSEQUENT KNEE ARTHROSCOPY ON (B)(6) 2025. ARTHROSCOPY REVEALED THAT THE GRAFT WAS FOUND TO HAVE BEEN BASICALLY DISINTEGRATED AND DISSOLVED WITH MULTIPLE SMALLER PIECES FLOATING AROUND THE JOINT. FIXATION WAS WHERE IT WAS WELL POSITIONED AND STILL INTACT IN THE POSTERIOR RIM. ONE LARGE TISSUE FRAGMENT WAS REMOVED AND SENT TO PATHOLOGY. IT DID NOT HAVE ANY RECOGNIZABLE APPEARANCE OF GRAFT MATERIAL. THERE WAS MILD TO MODERATE SYNOVITIS PRESENT THROUGHOUT THE JOINT. PATHOLOGY REPORT CAME BACK AS: "REACTIVE SYNOVIAL-LINED FIBRINOFIBROUS TISSUE WITH ACUTE INFLAMMATION". DUE TO CONCERN FOR POSSIBLE REACTION TO TYPE 1 COLLAGEN, ANOTHER GRAFT WAS NOT IMPLANTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
128123 REJUVAKNEE COLLAGEN MENISCUS IMPLANT OLC COLLAGEN MATRIX, INC. REJ075 MEN085241001 00813954026022

Patients

Seq Age Sex Outcome Treatment
1 47 YR Male Required Intervention