MAUDE Adverse Event Report: SYNTHES MONUMENT 8MM TI CURVED RADIAL STEM 44MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.028S

Device Problems Difficult to Insert (1316); Misassembled (1398); Fitting Problem (2183)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was not explanted.(b)(4) the investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing date: february 17, 2015 ¿ expiration date: january 31, 2020 (b)(4)) manufactured the ti curved radial stem (part 04.402.028s / lot 7785172) for synthes work orders.The supplier¿s certificate of compliance (dated december 9, 2014) indicates that the parts were made to and met the required specifications.The lot was inspected and conformed to the synthes, incoming final inspection sheet.No non-conformance reports were generated for this lot.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 curved radial head stem did not fit correctly into place during a left radial head prosthesis revision procedure.The purpose of the revision was to replace a short stem with a long stem as the patient had reported post-operative pain following the original procedure (which utilized a competitor's device).X-rays prior to the revision procedure indicated that the implanted device had "wollered out" or migrated.During the revision procedure, an 8mm curved radial stem was inserted after reaming.The surgeon indicated that the stem did not fit correctly.The head of the stem did not articulate with the capitulum and appeared to be pointing out backwards toward the olecranon.The implant was removed and reassembled on the back table.Upon reinsertion, the surgeon turned it 180 degrees; the device fit perfectly.A ninety (90) minute delay was noted.The procedure was completed without further incident.This report is 1 of 2 for (b)(4).

• Brand Name: 8MM TI CURVED RADIAL STEM 44MM-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: 5014011
• MDR Text Key: 23439708
• Report Number: 1719045-2015-10521
• 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
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 04.402.028S
• Device Lot Number: 7785172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR