MAUDE Adverse Event Report: SYNTHES MONUMENT 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL POLYMER

Catalog Number 04.402.007S

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed: dhr review, part number: 04.402.007s, synthes lot number: 7607058, supplier lot number: n/a, expiration date: 31-may-2019, release to warehouse date: 16-jul-2014, manufacturer: 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.Manufacturing location: supplier (b)(4).Packaged by: (b)(6).Manufacturing date: 16-jul-2014, expiration date: 31-may-2019, part #: 04.402.007s, lot#: 7607058 (sterile) - 7mm ti straight radial stem 26mm - sterile.Quantity (b)(4).Component parts reviewed: part 21024, lot 6190711 received from dynamet.Product certification received from dynamet met specification.Raw material receiving/put away checklist met requirements.Certificate of compliance received from avalign (nemcomed) meet specification.Inspection sheet for incoming final inspection met inspection acceptance criteria.No ncrs 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.Scn no: (b)(4), sterigenics (corona), ¿sterility documentation was reviewed and determined to be conforming.¿ 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 removal of a radial head prothesis that was implanted in 2015 was explanted on (b)(6) 2017 at 8:00am.No other information provided.The radial head was removed due to infection and the devices being loose.This complaint is for two (2) devices this report is 2 of 2 for (b)(4).

Manufacturer Narrative

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 STRAIGHT RADIAL STEM 26MM-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: 6902353
• MDR Text Key: 87726328
• Report Number: 1719045-2017-11001
• 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 Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• 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: 04.402.007S
• Device Lot Number: 7607058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 132