MAUDE Adverse Event Report: SYNTHES MONUMENT 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.022S

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implanted on an unknown date two years prior to hardware removal surgery.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was performed for part #: 09.402.022s, lot#: 7608118 (sterile) - 22 mm cocr radial head standard height/12.5 mm - sterile.Quantity 150: manufacturing location: supplier (b)(4).Packaged by: (b)(4), manufacturing date: 28-aug-2014, expiration date: 31-jul-2019: component parts reviewed: part 21022 lot 5317556 and part 41060 lot 7470574 were reviewed.Drawing for radial head prosthesis: a lot: 7425458 and lot: 7729736.Radial head prosthesis tray drawing: a lot: 7397013.Tyvek lidding: a lot: 7588620 and lot 7322523 reviewed and they meet specification.Certificate of compliance received from (b)(4) meet specification.Inspection sheet for incoming final inspection (b)(4) rev: c met inspection acceptance criteria.No non-conformance reports (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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 hardware removal was performed on (b)(6) 2017 due to infection, non-union and radial stem loosening.The original olecranon and radial head fracture repair procedure was performed on an unknown date two years ago.According to the surgeon, pre-hardware removal x-rays showed olecranon non-union and radial stem loosening.The patient experienced pain of the right elbow, which led her to seek follow-up with the surgeon.Removed hardware included: one olecranon plate, four 3.5 mm cortical screws, five 2.7 mm variable angle (va) locking screws, and a radial head and stem.The area was thoroughly washed out and cultures were taken.During the hardware removal, as one of the 2.7 mm locking screws was backed out of the olecranon plate, it broke at the head.The broken pieces were retrieved.Nothing was left behind in the patient.There was no reported surgical delay.It was noted that no broken screws were seen on the pre-operative x-rays; it is believed that this occurred during the hardware removal.Additional x-rays were required to confirm no fragments left behind.The procedure was completed successfully with the patient in stable condition.Culture results are pending.The patient is not scheduled for another procedure at this time.This report addresses hardware removal due to infection, non-union and radial stem loosening.The breakage of the 2.7 mm locking screw during the hardware removal procedure has been reported in the linked complaint (b)(4).This report is for one (1) 22 mm cocr radial head standard height/12.5 mm-sterile.This is report 2 of 5 for complaint (b)(4).

• Brand Name: 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-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: 6966917
• MDR Text Key: 89926358
• Report Number: 1719045-2017-11092
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 09.402.022S
• Device Lot Number: 7608118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention