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

Model Number ANGEL CPRP PROCESSING SET USM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Fever (1858); Failure of Implant (1924); Inflammation (1932); Reaction to Medicinal Component of Device (4574); Swelling/ Edema (4577)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported via a medwatch report that the patient had undergone two prior platelet rich plasma injections in the past, one in 2018 and the second in 2019.The physician reported that the patient did extremely well afterwards with great relief of their pain.The physician completed a third prp injection on the patient's right knee using abs-10063 (lot: 2020030011) under ultrasound guidance.The injection went well and was done with sterile technique.The patient did well for the first few days.However, the patient then started experiencing increased pain and swelling without redness, warmth, 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.The patient did not improve and was sent to the emergency room.The patient was seen by an ortho and also thought to be an inflammatory reaction.Pain continued and knee was once again drained and eventually grew out staph lugdunensis and the patient was sent back to the er.The patient was seen by infectious disease who thought the issue was septic arthritis.The patient underwent surgical washout and was treated with a prolonged course of iv antibiotics.

• Brand Name: ANGEL CPRP PROCESSING SET USM
• Type of Device: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11956467
• MDR Text Key: 254809515
• Report Number: 1220246-2021-03241
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867084001
• UDI-Public: 00888867084001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ANGEL CPRP PROCESSING SET USM
• Device Catalogue Number: ABS-10063
• Device Lot Number: 2020030011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other