MAUDE Adverse Event Report: SYNTHES MONUMENT 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Catalog Number 04.402.006S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(6) (b)(4).Implant date reported as end of (b)(6) 2016.Concomitant medical products: concomitant device therapy date reported as end of (b)(6) 2016.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(b)(4).Part #: 04.402.006s, lot#: 7785140 (sterile) - 6 mm ti straight radial stem 24 mm-sterile.Quantity 100.Raw material part 21014 lot 7557656 was reviewed.Inspection sheet - incoming final inspection - meets inspection acceptance criteria.Inspection certificate received meet 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: packaged by (b)(4).Manufacturing date: 15-apr-2015.Expiration date: 31-mar-2020.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 who initially underwent surgery for the implantation of the radial head prosthesis system at the end of (b)(6) 2016, was brought back to the operating room on (b)(6) 2017 for revision of the devices due to loosening of the radial stem.It was reported that there was not an issue with the radial head but that there was loosening of the stem in the shaft.An x-ray, taken during a post-operative visit on an unknown date, revealed loosening of the stem.It is unknown if the patient had any complaints of pain or discomfort at the time.The devices were removed intact and removal was described as they ¿fell right out¿.The patient was revised to a competitor¿s system.The surgery was completed successfully without delay and the patient reported as stable.Concomitant device: 20 mm radial head (09.402.220s, lot 6905664, quantity 1).This report is for one (1) radial stem.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (6mm ti straight radial stem 24mm-sterile, part number 04.402.006s, lot number 7785140).The subject device was returned with the complaint condition stating: the returned 04.402.006s titanium straight radial stem was reported to have been revised and explanted due to postoperative loosening.This complaint condition has been investigated and resulted in recall and the voluntary product removal of the radial head prosthesis system.Corrective and preventative action (capa) documents the investigation and the resulting actions and therefore no design clinical risk management (dcrm) review is required in this complaint.This complaint is unconfirmed as no x-rays or evidence was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Complaint was reviewed and determined to be a part of recall.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: 6MM TI STRAIGHT RADIAL STEM 24MM-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: 6500806
• MDR Text Key: 73062114
• Report Number: 1719045-2017-10325
• 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,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 04.402.006S
• Device Lot Number: 7785140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: RADIAL HEAD (09.402.220S, LOT 6905664, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Weight: 97