MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Catalog Number 04.402.010S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Date of device loosening is not known.Udi: (b)(4).Date of implant reported as approximately one year prior to explant.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.Part #: 04.402.010s, lot#: 7608055 (sterile) - 8mm ti straight radial stem 28mm-sterile, quantity 77.Raw material part 21014 lot number 6190711 reviewed.Raw material provided by (b)(4).(b)(4) certificate of compliance meets specification.Inspection sheet for incoming final inspection meets 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.¿ manufacturing location: supplier (b)(4), packaged by: (b)(4).Manufacturing date: 21-aug-2014.Expiration date: 31-jul-2019.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 the patient underwent a hardware removal of a radial head prosthesis system on (b)(6) 2017 due to loosening.One (1) 22mm cocr radial head standard height/12.5mm-sterile and one (1) 10mm titanium (ti) straight radial stem 32mm-sterile were removed intact.The initial implant procedure was performed on an unknown date, approximately one year ago.X-rays were taken on an unknown date.No surgical delay or patient harm.The procedure was completed successfully.This report is for one (1) 10mm ti straight radial stem.This is report 2 of 2 for (b)(4).

• Brand Name: 10MM TI STRAIGHT RADIAL STEM 32MM-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: 6618923
• MDR Text Key: 76885637
• Report Number: 1719045-2017-10541
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 04.402.010S
• Device Lot Number: 7608055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• 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
• Patient Weight: 91