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

Catalog Number 04.402.008S

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

Patient Problems Inflammation (1932); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional patient id - b)(6).Exact date of event is unknown.(other): udi # (b)(4).Device history records review was completed for part# 04.402.008s, lot# 7608053.Manufacturing location: supplier nemcomed, packaged by: monument, manufacturing date: jul 24, 2014, expiration date: jun 30, 2019.No non conformance reports were generated during production.Review of the device history records 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.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device 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 on (b)(6) 2016, patient underwent fourth (4th) revision surgery.The surgeon excised the right radial head implant.Patient was not further revised due to the bone loss.Tissue samples from revision surgery were negative for infection.Tissue showed some hemosiderin deposits, but no fragmentation of the implant, and no metal debris in the tissues.There was no metal debris in the radius endosteal canal.According to surgeon, the bone had been mechanically ground by the prosthesis.Patient/status was reported as stable after the procedure.Procedure was successfully completed and no surgical delays were reported.Patient had inflammation and had pain symptoms in his right elbow, with swelling.Radiographs confirmed osteolysis.This complaint (b)(4), captures the fourth (4th) revision surgery and following com numbers captures the previous three (3) revision surgeries: (b)(4): 1st revision, com-(b)(4): 2nd revision, (b)(4): 3rd revision.This report is for one (1) straight radial stem.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject devices (one (1) 22mm cocr radial head standard height, 12.5mm, sterile (part number 09.402.022s / lot number 7608118 and one (1) 8mm titanium straight radial stem, 28mm, sterile (part number 04.402.008s / lot number 7608053).The complaint condition is confirmed as the internal review of the provided x-rays was able to confirmed decreased bone density in the area around the stem.However, no further information could be gathered from the x-rays.A device history record (dhr) review, visual inspection, functional test, and drawing review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The returned radial head and radial stem attach to form a two-piece construct.This construct is intended for primary and revision joint replacement of the radial head.This information is provided per the radial head prosthesis system technique guide.The radial head and radial stem were each received intact and in functional condition.Light surface wear consistent with implant and explant was observed.No functional issue was identified.The implant has been removed from the patient; no comment can be made concerning the complaint condition from the implants themselves.An internal review of the provided x-rays was performed and confirmed decreased bone density in the area around the stem.No further information could be gathered from the x-rays.Based on this information the complaint condition is confirmed and no inconsistent with the reported condition were observed.Replication of the complaint condition is not applicable as the issues are patient related.A review of the current design drawing / manufactured revision for the radial head and the radial stem was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A definitive root cause could not be determined.The radial head and radial stem were each received intact and in functional condition.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.

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIA, 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6063578
• MDR Text Key: 58658190
• Report Number: 1719045-2016-10791
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7608053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 77