MAUDE Adverse Event Report: ARTHREX, INC. IBAL PATELLA IMPL DOME,37X 10 MM; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number IBAL PATELLA IMPL DOME,37X 10 MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091); Fluid Discharge (2686)

Event Date 09/17/2018

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 therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.

Event Description

It has been reported that on (b)(6) 2015 a patient underwent a total knee procedure.The tibial tray implanted during this procedure was ar-503ttth, lot 1380710.Patient developed a serious infection in his knee which required having to have fluid drawn from his knee, the parts then had to be explanted in a second surgery where a temporary spacer was put in place, he then underwent a lengthy series of iv antibiotics and eventually had another surgery to redo the knee with new implants.Patient is currently doing well.Patient did not have all of his records available at the time of call so additional information has been requested.Additional information obtained 9/21/2018: patient underwent a right tka procedure on (b)(6) 2015 during which the following devices were implanted: tibial tray implant ar-503-ttth lot 1380710, femoral implant ar-516-7r lot 1355182, tibial bearing implant ar-513-bh12 lot 113601341, and patella implant ar-504-psd0 lot 113601439.Almost immediately after having the procedure the patient began to have infection symptoms which included: swelling, redness and the incision was leaking fluid including blood.On (b)(6) 2015 the patient's knee was drained to provide some relief however the symptoms did not dissipate and continued.On (b)(6) 2016 the patient underwent surgery with a different surgeon at a different facility.During the procedure the four original tka implants were explanted and a temporary spacer was inserted.New implants could not be inserted until the infection was allowed to clear over 6 weeks and the patient underwent iv antibiotic treatment.On (b)(6) 2016 the second surgeon then went back in (at the same facility as the second surgery) and was able to insert another manufacturer's tka implants.At time of report patient is doing well.Patient is unaware if the devices were kept by the facility or not.

• Brand Name: IBAL PATELLA IMPL DOME,37X 10 MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 7943603
• MDR Text Key: 123069236
• Report Number: 1220246-2018-00695
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 00888867035577
• UDI-Public: 00888867035577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: IBAL PATELLA IMPL DOME,37X 10 MM
• Device Catalogue Number: AR-504-PSD0
• Device Lot Number: 113601439
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2018
• Date Device Manufactured: 12/22/2014
• 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): Other
• Patient Age: 57 YR