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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Fall (1848); Bone Fracture(s) (1870); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

Additional patient information: patient (b)(6).Exact date of secondary bone breakage is unknown.(b)(4).The original implant procedure was performed on an unknown date approximately two (2) years ago.Per facility, the complainant parts have been discarded and are no longer available for evaluation.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history record review: manufacturing location: (b)(4) - manufacturing date: march 15, 2013 - expiration date: february 28, 2018.No non-conformance reports (ncr) 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.The sterility documentation was reviewed and determined to be conforming.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.

Event Description

It was reported that a patient was originally implanted with a radial head and stem prosthesis approximately two (2) years ago to repair an elbow joint.On an unknown date thereafter, the patient suffered a fall and broke the bone just distal to the tip of the radial head.Per the surgeon, the patient's bone broke at that particular location due to the loosening of the radial head.The surgeon indicated that the wobbling / loosening aspect of the radial head may have eroded some of the cortical bone, thereby weakening it.As a result, the patient returned to the operating room on (b)(6) 2015 for revision.The original hardware was removed intact.Prior to this revision, it is unknown whether or not the patient had achieved union, fusion, or mal-union.The patient was not revised with any new implants.The procedure was successfully completed with no reports of surgical delay or intervention.The patient's post-operative status was reported as "stable." this report is 2 of 2 for (b)(4).

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5357357
• MDR Text Key: 35539492
• Report Number: 1719045-2016-10037
• 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: Other
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 7012154
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 91