MAUDE Adverse Event Report: SYNTHES MONUMENT 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number 04.402.008S

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: (b)(6).(b)(4).Subject device has been received and is currently in the evaluation process.Dhr review ¿ part number: (b)(4).Lot number: 7012223.Release to warehouse date: april 4, 2013.Manufactured by synthes (b)(4).Expiration date: february 28, 2018.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 had right radial head revision surgery on (b)(6) 2015 due to the implant being oversized and noted to be loose and mal-positioned.The implants were removed without difficulty and no new implants were placed.The procedure was completed with no reported surgical delay.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the complaint condition for the 09.402.024 lot number 6892441 radial head and 04.402.008 lot number 7012223 radial stem was likely caused by an incorrectly sized implant or patient non-compliance; however, this complaint is not likely a result of any design related deficiency.Per the technique guide, the 09.402.024 radial head and 04.402.008 radial stem are implants routinely used in the radial head prosthesis system.The devices were returned and reported to have become loosened and mal-positioned.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 to compare for loosening of the implants.It is likely that an incorrectly sized implant or patient noncompliance has led to this complaint condition.The radial head was manufactured in july 2012 and is over three years old.The radial stem was manufactured in may 2013 and is over two years old.The balance of the returned devices is in fairly worn condition consistent with implantation and removal.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does not agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.No non-conformance reports germane to the complaint condition were generated during the production of this device.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.

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-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: 5229796
• MDR Text Key: 31388255
• Report Number: 1719045-2015-10743
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7012223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90