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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional patient identifier: (b)(6).Patient weight not available for reporting.Date of device loosening is not known.(b)(4).Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review.Part number: 04.402.009s.Synthes lot number: 7013305.Supplier lot number: n/a.Release to warehouse date: 18-may-2013.Expiration date: 30-apr-2018.Manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient was implanted with the radial head prosthesis on (b)(6) 2016.X-ray taken during the one-year follow up revealed the device is loosening.Patient reports no pain, some occasional clicking, stable elbow, very good range of motion (rom), working with no problem.No patient harm reported, patient condition reported as stable.Devices remain implanted.This report is for one (1) 9mm straight radial stem 30mm.This is report 1 of 2 for com-(b)(4).

Manufacturer Narrative

Update to event.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

No action has yet been taken and no additional medical/surgical intervention was required.Surgeon will continue to observe patient condition through follow up visits.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Appropriate actions have been initiated/taken to address the matter.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient condition is well and stable and no need and no plans for revision, patient is on follow ups.Further intervention will only depend on future follow up on patient conditions.

• 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: 6926553
• MDR Text Key: 89943465
• Report Number: 1719045-2017-11029
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7013305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1