MAUDE Adverse Event Report: ARTHREX INC. ARTHREX ANGEL C PRP PROCESSING SET; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number ABS-10063

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)

Event Date 10/21/2020

Event Type  Injury  

Event Description

A (b)(6) yr old male with right knee chondromalacia, right knee osteoarthritis, right knee chondral defect.Previously seen by me and had undergone 2 prior platelet rich plasma injections in the past on (b)(6) 2019 and on (b)(6) 2018 and did extremely well afterwards with great relief of his pain.We completed a 3rd prp injection to the right knee joint under ultrasound guidance which went well and was done with sterile technique.He did well for first few days.However then had increased pain and swelling without redness, warmth or fevers or chills.Fluid was drained and sent for analysis and thought to be a pseudoseptic inflammatory reaction.Culture later grew out staph lugdunensis after a few days in thio broth tube only, and thought to be skin contaminant.He did not improve and was sent to er.Seen by ortho and also thought to be an inflammatory reaction.Pain continued and knee was once again drained and eventually grew out staph lugdunensis and sent back to the er.Seen by infectious disease who thought was septic arthritis.He underwent surgical washout and was treated with a prolonged course of iv antibiotics.Fda safety report id # (b)(4).

• Brand Name: ARTHREX ANGEL C PRP PROCESSING SET
• Type of Device: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): ARTHREX INC. ; naples FL 34108
• MDR Report Key: 11731508
• MDR Text Key: 247703359
• Report Number: MW5100990
• Device Sequence Number: 1
• Product Code: ORG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ABS-10063
• Device Lot Number: 2020030011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 73