MAUDE Adverse Event Report: SYNTHES MONUMENT 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.008S

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Manufacturing location: supplier (b)(4), packaged by: (b)(4).Manufacturing date: 29-jul-2016 expiration date: 30-jun-2021 part #: 04.402.008s, lot#: h027982 (sterile) - 8mm ti straight radial stem 28mm-sterile, quantity 14.Inspection sheet for incoming final inspection meets specification.Raw material part 21014 lot number 6955294 reviewed.Raw material provided by dynamet incorporated.Product certification received from dynamet for titanium meet specification.Raw material receiving/putaway checklist meet specification.Certificate of compliance from nemcomed (avalign) met specification.Packaging component reviewed and they meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient underwent a radial head prosthesis removal and revision on (b)(6) 2017.The original implant procedure was performed on (b)(6) 2016.The patient had regular follow up visits with the surgeon during the following six months.In (b)(6) 2017, he met with his surgeon complaining of increasing pain in the left forearm.X-rays were taken, and the surgeon pointed out that he observed some osteolysis around the implant stem, but at that time it was minor and he did not believe it was a cause for concern.The patient had follow-up visits with the surgeon in (b)(6) and again in (b)(6) 2017.At both visits the patient complained of ongoing pain in the forearm, in the crook of the arm and along the radial bone.During the (b)(6) 2017 visit, the surgeon told the patient that the osteolysis around the stem had become more significant, and that there was a very noticeable gap between the radial bone and the implant stem.During this visit the surgeon discussed the potential for needing revision surgery.Throughout the remainder of the month of (b)(6) and the first two weeks of (b)(6), the patient continued to have significant pain, as well as clicking, grinding and instability in his left elbow.After a visit to the surgeon on (b)(6) 2017, revision surgery was scheduled on (b)(6) 2017.After the surgery, the surgeon reported that the radial head implant was so loose that he could pull the device out by hand.He said because of the loose device, the patient had a fracture of the radius bone where the implant entered the bone.He said the bone was "egg shell" thin and that he had to remove 1cm of the radius bone to install a new device from a different manufacturer.He also said there was soft tissue damage as well as wear in the cartilage from the device being loose.The patient is undergoing occupational therapy for the elbow in order to regain the range of motion he lost due to having the radial head revision surgery.Concomitant devices reported: 24mm cocr radial head standard height/13.0mm-sterile (part 09.402.024s, lot 7683419, quantity 1).This report is for one (1) 8mm straight radial stem 28mm this is report 1 of 1 for (b)(4).

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6990604
• MDR Text Key: 90677724
• Report Number: 1719045-2017-11136
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 04.402.008S
• Device Lot Number: H027982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: RADIAL HEAD (09.402.024S, LOT 7683419, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Weight: 75