MAUDE Adverse Event Report: SYNTHES MONUMENT 9MM TI STRAIGHT RADIAL STEM; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.009S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient¿s identifier and weight are not available for reporting.Udi: (b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed for part #: 04.402.009s, lot#: 7917010 (sterile) - 9 mm ti straight radial stem 30mm-sterile.Quantity 25: manufacturing location: supplier (b)(4), packaged by (b)(4), manufacturing date: 15-may-2015, expiration date: 30-apr-2020: raw material part 21014 lot 7557656 was reviewed.Raw material was received from (b)(4.Certified test report for titanium received from (b)(4) meet specification.Inspection certificate received from (b)(4) corporation meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet ¿ incoming final inspection meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.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 patient underwent the removal of a radial head and stem on (b)(6) 2017 due to a reported loosening of the stem making both the radial head and stem unstable.The patient was reported to be in stable condition following the procedure.Procedure was completed successfully.Concomitant device reported: 28mm cocr radial head (part # 09.402.028, lot # 7608121, quantity 1).This report is for one (1) 9mm ti straight radial stem 30mm-sterile this is report 1 of 1 for complaint (b)(4).

• Brand Name: 9MM TI STRAIGHT RADIAL STEM
• 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: 6976239
• MDR Text Key: 90208272
• Report Number: 1719045-2017-11115
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7917010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: RADIAL HEAD (PART 09.402.028, LOT 7608121, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR