MAUDE Adverse Event Report: SYNTHES MONUMENT 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.009S

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: (b)(6).Event date: unknown.(b)(4).A review of the device history records has been requested and is currently pending completion.The radial stem was loose postoperatively and required removal.The patient will need an additional surgery in the future to stabilize the site.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 initially underwent surgery on (b)(6) 2016 for the implantation of the radial head prosthesis system.The devices were monitored via x-ray on a monthly basis since (b)(6) 2016 and revealed progressively advanced lucency.The patient was brought back to the operating room on (b)(6) 2017 for removal of both the radial head and stem.It was reported that it was just the radial stem that was loose.The devices were removed without any issue and the site was cultured for infection per standard procedure.It was confirmed post-operatively that there was not an infection.It was reported that the surgeon did not revise the patient to new hardware at the time of surgery due to severe bone loss, lack of obvious instability and possible infection.However; the surgeon believes he will need to go back in to "fix" the patient at some point.It was also reported that the patient had a comminuted proximal ulna shaft fracture and was implanted with a synthes variable angle locking compression plate (lcp) plate and approximately 15 screws on an unknown date and the devices remain implanted.The surgery was completed successfully, without delay, and the patient reported as stable.Concomitant device: radial head (part #09.402.022, lot #9983217, quantity 1), va lcp plate (part #unknown, lot #unknown, quantity 1) and screws (part #unknown, lot #unknown, quantity, approximately 15).This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Expiration date, udi: (b)(4).Sterile part 04.402.009s, lot 7607066; non-sterile part 04.402.009, lot 7608054: manufacturing location: supplier (b)(4), packaged by (b)(4).Manufacturing date: october 21, 2014.Expiration date: august 31, 2019.Raw material was reviewed and meets inspection acceptance criteria.Certificate of compliance received from avalign meet specification.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 reviewed and determined to be conforming.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.

Manufacturer Narrative

A product investigation was performed on the returned subject device.The returned 04.402.009s titanium straight radial stem and 09.402.022s cocr radial head were reported to have been revised and explanted due to postoperative loosening.This complaint is unconfirmed as no x-rays were provided.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 has been initiated.Whether this complaint can be replicated at customer quality (cq) is not applicable for this condition.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: 9MM TI STRAIGHT RADIAL STEM 30MM-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: 6429856
• MDR Text Key: 70737448
• Report Number: 1719045-2017-10252
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7608054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: PLATE (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1; RADIAL HEAD (PART #09.402.022, LOT #9983217, QTY 1; SCREWS (PART AND LOT #UNKNOWN, QTY APPROX. 15)
• Patient Outcome(s): Required Intervention
• Patient Weight: 122