MAUDE Adverse Event Report: SYNTHES MONUMENT 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL

Catalog Number 04.402.008S

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: (b)(6).Event date: unknown.(b)(4).Not explanted.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 had a right ulna and proximal radial fracture and was implanted with radial head/stem on (b)(6) 2016.The patient had an x-ray taken (unavailable) at a one-year follow-up visit on (b)(6) 2017; the surgeon noted the stem had loosened.Surgical delay and patient outcome were unknown.No surgery is planned; he will just monitor the patient.No additional information available.This is for 1 part concomitant devices reported: radial head (part #09.402.222s, lot #unknown, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL
• 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: 6413084
• MDR Text Key: 70220258
• Report Number: 2520274-2017-10915
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.008S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided; 10/12/2017; 10/12/2017
• Supplement Dates FDA Received: 03/17/2017; 10/12/2017; 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 #09.402.222S, LOT #UNK, QTY.1
• Patient Weight: 76