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 Problems Erosion (1750); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for one unknown radial stem size 9mm.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.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 radial head prosthesis, implanted on (b)(6) 2014 was found to be loose a number of months prior to being explanted on (b)(6) 2015.The device was found during an x-ray to be loosening in the bone and it was noted by the surgeon during the explanting of the device that there was no bone ingrowth evident.The device was fully and successfully explanted with no fragments being left behind.No additional medical intervention was required and no additional devices were implanted during the revision surgery.The status of the patient was reported as satisfactory; no known instability of the joint at the time of the report.This report is for one unknown radial stem size 9mm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(4).Manufacturing date: 18june2014.Expiration date: 31may2019.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.A product investigation was completed: the complaint condition for the 09.402.226 lot number 6905624 radial head and 04.402.009 lot number 7607066 radial stem was likely caused by an incorrectly sized implant or patient noncompliance; however, this complaint is not likely a result of any design related deficiency.Per the technique guide, the 09.402.226 radial head and 04.402.009 radial stem are implants routinely used in the radial head prosthesis system.The radial head was manufactured in february 2013 and is over two years old.The radial stem was manufactured in june 2014 and is over a year old.The balance of the returned devices is in fairly worn condition consistent with implantation and removal.Relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The devices were returned and reported to have become loosened.This condition is unconfirmed; the implant was removed from the patient, but loosening of the implant cannot be confirmed without preoperative and postoperative x-rays being provided.It is likely that an incorrectly sized implant or patient noncompliance has led to this complaint condition.No design related issues were found that would contribute to this complaint 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.

Manufacturer Narrative

The date of awareness was originally reported as october 19, 2015 in error on the initial medwatch.The correct awareness date for the complained event was october 14, 2015.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: 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5210412
• MDR Text Key: 30710555
• Report Number: 2520274-2015-17145
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7607066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention