MAUDE Adverse Event Report: DSM BIOMEDICAL ARTHREX DX REINFORCEMENT MATTRIX; MESH, SURGICAL, PRODUCT CODE: FTM

Device Problem Insufficient Information (3190)

Patient Problem Local Reaction (2035)

Event Type  malfunction  

Manufacturer Narrative

During a post-market surveillance search of clinical literature, the manufacturer found a paper (polacek m.Arthroscopic superior capsular reconstruction with acellular porcine dermal xenograft for the treatment of massive irreparable rotator cuff tears.Arthrosc sports med rehabil.2019 nov 13;1(1):e75-e84.) which outlines that patient #5 experienced a complication post-operative after the implantation of arthrex dx reinforcement matrix as part of superior capsular reconstruction (scr) surgery.The patient experienced an adverse reaction described as an "acute immunologic reaction" (pain, swelling, secretion) but there was no surgical site infection.Revisional surgery was performed and the surgeon noted that the device had degraded into white particles.The device was explanted.Patient later required a revisional scr and rehabilitation before experiencing clinical improvement.

Event Description

During a post-market surveillance search of clinical literature, the manufacturer found a paper (polacek m.Arthroscopic superior capsular reconstruction with acellular porcine dermal xenograft for the treatment of massive irreparable rotator cuff tears.Arthrosc sports med rehabil.2019 nov 13;1(1):e75-e84.) which outlines that patient #5 experienced a complication post-operative after the implantation of arthrex dx reinforcement matrix as part of superior capsular reconstruction (scr) surgery.The patient experienced an adverse reaction described as an "acute immunologic reaction" (pain, swelling, secretion) but there was no surgical site infection.Revisional surgery was performed and the surgeon noted that the device had degraded into white particles.The device was explanted.Patient later required a revisional scr and rehabilitation before experiencing clinical improvement.

• Brand Name: ARTHREX DX REINFORCEMENT MATTRIX
• Type of Device: MESH, SURGICAL, PRODUCT CODE: FTM
• Manufacturer (Section D): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer (Section G): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: chelsea kozior ; 735 pennsylvania drive; exton, PA 19341
• MDR Report Key: 12061325
• MDR Text Key: 264595216
• Report Number: 2530154-2021-00002
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K091499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention