MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. REJUVAKNEE; COLLAGEN MENISCUS IMPLANT

Model Number	REJ075
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Inflammation (1932); Fibrosis (3167)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: REJUVAKNEE
• Common Device Name: COLLAGEN MENISCUS IMPLANT
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 24066012
• Report Number: 2249852-2026-00003
• Device Sequence Number: 9350933
• Product Code: OLC
• UDI-Device Identifier: 00813954026022
• UDI-Public: (01)00813954026022(17)261031(10)MEN085241001
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K242302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: REJ075
• Device Catalogue Number: REJ075
• Device Lot Number: MEN085241001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male