MAUDE Adverse Event Report: SYNTHES MONUMENT 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.027S

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient height is (b)(6) and bmi is (b)(6).Date of event is unknown.Udi: (b)(4).Implant date is unknown.It occurred in 2014.Explant date is not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Therapy date of concomitant device is unknown.Dhr review for part # 04.402.027s, supplier lot # 7012312.Release to warehouse date: 26-mar-2013.Expiration date: feb-2008.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product 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.

Event Description

It was reported that a patient underwent removal of a radial head and stem on (b)(6) 2017 due to pain and loosening of the stem.The radial head and stem were originally implanted on an unknown date in 2014.Approximately three weeks prior to implant removal, the patient experienced pain; x-rays confirmed loosening of the stem.The system was successfully removed intact with no delay.The patient outcome was reported as good.Concomitant devices reported: radial head - 20mm cocr radial head, +0 (part # 09.402.020, lot # 7601474, quantity # 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Complaint part was returned.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Corrected data: (b)(4).Device expiration date is feb 2018.Exact date is unknown.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

Additional narrative: product development investigation was completed.The returned 04.402.027s 7mm ti curved radial stem 42mm-sterile (lot# 7012312) was reported to have been explanted due to patient complaining about postoperative pain.It was reported that x-rays taken confirmed loosening of the stem.This complaint condition has been investigated and the relevant actions have been taken to address this issue.Corrected data: udi# (b)(4).Device expiration date is feb 2008.Exact date is unknown.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: 7MM TI CURVED RADIAL STEM 42MM-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: 6736325
• MDR Text Key: 80808659
• Report Number: 1719045-2017-10685
• 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,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7012312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: PART # 09.402.020, LOT # 7601474, QUANTITY # 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 74