MAUDE Adverse Event Report: SYNTHES MONUMENT 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.020S

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional patient information: patient height reported as 5 feet 2 inches.Patient initials are (b)(6).Additional patient identification numbers (for the original procedure) include (b)(6).(b)(4).Product investigation summary: the complaint condition for the radial head (part 09.402.020 / lot 7693233) and radial stem (part 04.402.007 / lot 7683416) was likely caused by an incorrectly sized implant or patient noncompliance; however, this complaint is not likely a result of any design related deficiency.The radial head and radial stem are implants routinely used in the radial head prosthesis system.The devices were returned and reported to have caused patient pain and to have loosened.This condition is unconfirmed; the implant was removed from the patient, but confirming loosening of the implant would require x-rays, which were not provided.It is likely that an incorrectly sized implant or patient noncompliance has led to this complaint condition.The radial head was manufactured in october, 2014 and is over a year old.The radial stem was manufactured in november, 2014 and is a year old.The balance of the returned devices is in fairly worn condition consistent with implantation and removal.The relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used as recommended.The condition of the returned device does not agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.No design related issues were found that would contribute to this complaint condition.Device history record review: manufacturing location: (b)(4).Manufacturing date: october 21, 2014 - expiration date: september 30, 2019.No non-conformance reports 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 also reviewed and determined to be conforming.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 a left elbow radial head prosthesis revision procedure was performed on (b)(6) 2015 following patient complaints of pain in the left wrist and elbow.The prosthesis was noted to have loosened and toggled in the broached area.No bony growth was observed.Additionally, there was noted shortening of the left forearm.During the original surgical procedure, the radial head and stem were implanted along with a cable.During the revision, the radial head and stem were removed, but the cable remained implanted.The patient was revised to a non-synthes, cemented radial head prosthesis.Intraoperative x-rays were taken and the procedure was completed successfully without delay.Upon review of the devices, the surgeon expressed that the synthes implant did not look porous enough to promote bony growth.This report is 2 of 2 for (b)(4).

• Brand Name: 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5237095
• MDR Text Key: 31635050
• Report Number: 1719045-2015-10754
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• 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
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 09.402.020S
• Device Lot Number: 7693233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 69