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

Catalog Number 04.402.008S

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record review was performed on part #: 04.402.008s, lot#: h044643 (sterile).8mm ti straight radial stem 28mm-steril, quantity (b)(4): manufactured by: (b)(4), packaged by: (b)(4), manufacturing date: 09-mar-2016, expiration date: 28-feb-2021.No non-conformance reports (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.Sterility documentation was reviewed and determined to be conforming.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 was implanted with a radial head and radial stem in the proximal radius on (b)(6) 2016.No reported issues with initial surgery.Postoperatively, on an unknown date the patient reported pain, discomfort and impingement.Patient was seen by a surgeon on (b)(6) 2017.It is unknown when x-rays were taken however; x-rays showed that the radial head is impinging on the patient¿s capitulum.Surgeon believed that the radial stem has loosened and is causing the impingement.A revision surgery has been rescheduled for (b)(6) 2017.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

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 fell off a four feet ladder and landed directly on his elbow injuring his proximal radius and proximal ulna on unknown date.Patient sustained a type ii b coronoid fracture at the proximal ulna and was not surgically fixed with hardware.Postoperatively patient also complained about loosening.Revision surgery occurred on (b)(6) 2017 was completed successfully with no surgical delay and patient was reported as stable.Both implants were explanted intact and new radial head and new radial stem was implanted with bone graft without any issues.All the new implants used in revision surgery were non - synthes.X-rays taken post op (after (b)(6) 2016) surgery) were not available for return.Both radial head and radial stem were not available for return.

Manufacturer Narrative

Complaint was reviewed and determined to be a part of recall.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6352544
• MDR Text Key: 68114151
• Report Number: 1719045-2017-10136
• 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: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 04.402.008S
• Device Lot Number: H044643
• 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
• Date Device Manufactured: 03/09/2016
• 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 Age: 51 YR
• Patient Weight: 129