MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOID, PE WITH PEG, LARGE

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994); Rash (2033)

Event Date 08/26/2016

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.Device disposition was unknown by reporter.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

A patient reported that on (b)(6) 2016 he underwent a shoulder replacement surgery during which arthrex a patient reported that on (b)(6) 2016 he underwent a shoulder replacement surgery during which arthrex products were implanted into his shoulder.Patient developed an infection in his shoulder and on (b)(6) 2016 the surgeon performed a procedure to clean out the surgical site.No implants were removed at that time.The issues with infection continued and on (b)(6) 2016 the surgeon performed a revision procedure and removed the original arthrex products from patient's shoulder and replaced them with new arthrex products.Approximately 2 months after the (b)(6) 2016 procedure patient began having a rash under his armpit that has not gone away.In addition patient has significant pain in his shoulder.Patient had been doing rehab since the (b)(6) 2016 surgery but recently stopped rehab as it was not having any effect and the pain has continued along with the rash.Patient's surgeon has recommended another surgery on this same shoulder and has proposed doing a reverse total shoulder procedure.Patient obtained a second opinion from a surgeon in (b)(6) who concurred that another surgery is needed.In order to do the total reverse shoulder procedure the surgeon plans to perform surgery to remove the existing arthrex products, place an antibiotic spacer in the shoulder for 6 weeks and then bring patient back in again to perform the actual implant procedure to install the arthrex reverse shoulder implants.Patient has seen an allergist who wants to test him for metal allergies to the products that have been used to date.All procedures to date have been performed by the same surgeon at the same facility.Patient's upcoming procedures would also be performed by same surgeon at same facility.At the time of patient's initial report he did not have any information with regard to the part numbers of any previous arthrex products that have been used.Arthrex has requested that patient obtain part/lot numbers from facility implant logs as well as operative reports from each of the procedures to date.Additional information obtained 8/24/2018: the patient states his rash began after the (b)(6) 2016 procedure and months prior to the (b)(6) 2016 procedure to clean out the surgical site.Patient has started therapy approximately three weeks after the initial (b)(6) 2016 procedure.Patient has seen skin doctors for the rash which did not help.Patient is in the process of obtaining the implant log for part numbers.Additional information obtained 10/4/2018: the patient has confirmed via implant log that there were no arthrex devices implanted during the (b)(6) 2016 procedure, all implants during this procedure were from other manufacturers.There was an arthrex ar-9105-03, glenoid poly with peg large, implanted during the (b)(6) 2016 procedure along with devices from other manufacturers.Material composition of the ar-9105-03 has been provided to the patient.Patient has stated that he cannot get any further into the issue that he has.Therefore, at this time no further information is expected.

• Brand Name: GLENOID, PE WITH PEG, LARGE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 8002063
• MDR Text Key: 124964277
• Report Number: 1220246-2018-00713
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057333
• UDI-Public: 00888867057333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOID, PE WITH PEG, LARGE
• Device Catalogue Number: AR-9105-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No
• 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