MAUDE Adverse Event Report: SYNTHES MONUMENT UNKNOWN RADIAL STEM; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Unintended Movement (3026)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown - radial stem/unknown lot number.Device is not expected to be returned for manufacturer review/investigation.(b)(6).The radial stem was identified on x-ray as loosening and the patient is experiencing discomfort.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that a patient had a surgery and radial head prosthesis were implanted.The patient is satisfied with the result but not totally free of discomfort.On x-rays was seen that the shaft had loosen post-operatively.No revision surgery will be performed.No information available about patient condition and outcome.This complaint involves 2 parts.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Parts were not returned for evaluation.The investigation has confirmed that these implants are subjected to delivery stop and the parts are consequently blocked in the enterprise resource planning system.In addition, on 30 december 2016 synthes (b)(4) has initiated a voluntary medical device removal (recall) of the depuy synthes radial head prosthesis system due to the possibility that the radial stem may loosen post-operatively at the stem bone interface.Any related investigations and assessment of the risks associated with this system will be covered under recall and corrective and preventative actions were initiated in order to determine the root cause(s) and document the correction(s), corrective action(s) and/or preventive action(s).Patient i.D.Is (b)(6).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

Z number was initially reported by error.Entered z number.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: UNKNOWN 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: 6408496
• MDR Text Key: 70055933
• Report Number: 2520274-2017-10897
• 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,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided; 10/12/2017
• Supplement Dates FDA Received: 04/25/2017; 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
• Patient Outcome(s): Congenital Anomaly
• Patient Weight: 95