MAUDE Adverse Event Report: SYNTHES MONUMENT 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.024S

Device Problems Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Date of event is unknown.This report is for one (1) unknown 24 mm radial head.Part and lot number is unknown.Without a valid part and lot number, udi is not available.Device is not expected to be returned for manufacturer review/investigation.The (510k): unknown.(b)(4).Internal review of the provided x-rays revealed that the radiographs show an excellent placement of the radial head prosthesis (rhp).One set is early on shows no radiolucency or ¿haloing¿.The more recent set (no dates on films) show slight radiolucency.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 underwent a left radial head fracture repair with a radial head prosthesis on (b)(6) 2016.On (b)(6) 2017, the patient presented with complaints of left forearm pain.X-rays taken that day showed "haloing" (lucency) around the radial head prosthesis stem.Lab results showed no sign of infection.A hardware removal procedure was performed on (b)(6) 2017 successfully.This report is for one (1) unknown 24 mm radial head.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Patient bmi is (b)(6).Udi: (b)(4).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

After the original procedure on (b)(6) 2016, as the patient went through physical therapy and follow-up visits, his forearm and elbow pain worsened.On (b)(6) 2017, he was told that the x-rays showed the implant in his arm had loosened.He underwent a hardware removal and revision on (b)(6) 2017.The patient continues to undergo physical therapy and follow-up visits with his surgeon, and his pain continues.

Manufacturer Narrative

Manufacturer was updated in (b)(4).Complaint was reviewed and determined to be a part of recall updated.Corrected data: udi# (b)(4).Expiration date unknown (10) lot number unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-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: 6420442
• MDR Text Key: 70432421
• Report Number: 2520274-2017-10950
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.402.024S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82