MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI CURVED RADIAL STEM 44MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.028S

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial stem /unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes legal representative without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2018, the patient underwent revision surgery due to the loosening of the radial head prosthesis which the patient experience increasing pain, weakness, loss of motion and decreased the function of the elbow.Originally, the patient underwent open reduction internal fixation for radial head replacement on (b)(6) 2016, due to a 4-part comminuted right radial head fracture.The patient was treated with depuy synthes radial head system.The surgical delay was unknown.The procedure outcome was successfully completed, and the patient status was stable.This report is for one (1) radial head prosthesis: radial stem.This is report 1 of 2 for (b)(4).

Event Description

Updated event description: it was reported that on (b)(6) 2018, the patient underwent revision surgery due to the loosening of the radial head prosthesis which the patient experience increasing pain, weakness, loss of motion and decreased the function of the elbow.The screw was loosened on the synthes radial head implant and the head was removed.The stem was loose and was removed as well.Imaging demonstrated widening and scalloping of the proximal radius with extreme thinning of the lateral cortex.Procedure was done to maintain radial anatomy, specifically pro/supination strength and avoiding malunion, painful nonunion reportedly, the patient underwent open reduction internal fixation for radial head replacement on (b)(6) 2016, due to a 4-part comminuted right radial head fracture.The patient was implanted with a synthes radial head and stem.Postoperatively, the patient underwent a left knee arthroscopy and partial medial menisectomy/excisional biopsy ganglion cyst on (b)(6) 2017 due to left knee and swelling.Exam and imaging shows tear of the medial meniscus with a large ganglion cyst near pes anserine bursa that was communicating with the medial compartment.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Patient's height is reported as 6'0".Customer quality investigation: the complaint device was not received for investigation.The pictures were reviewed and based on the pictures alone us cq can confirm the complaint.The implant appears to have loosened in the implant site as seen in image.This is contrasted with another image where the implant is in the correct position.There are known issues with the radial head implants that are captured in corrective and preventative action (capa).There is also a recall (recall# 555531) that was initiated as part of field action investigation where ¿device loosening¿ was identified as a high harm and contributed to the recall of the product.Based on the images, capa, hhe and field action information us cq can confirm the complaint for loosening.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.However, based on previous complaints, the radial head prosthesis system (rhp system) was recalled under recall# 555531.Any related investigations and assessment of the risks associated with this system will be covered under recall# 555531 and hhe-2016-180 investigations.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.See related actions a device history record (dhr) review was conducted: manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument, release to warehouse date: 02-jul-2012, expiration date: 01-may-2017, part number: 04.402.028s, 8mm ti curved radial stem 44mm ¿ sterile, lot number: 6970383 (sterile) ¿ pulled from lot number: 6873703.Lot quantity: (b)(4).Work order travelers met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21069, tialnbri18.00, lot number: 6737206, lot quantity: (b)(4).This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the 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.

• Brand Name: 8MM TI CURVED RADIAL STEM 44MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8660212
• MDR Text Key: 146719347
• Report Number: 2939274-2019-58401
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 04.402.028S
• Device Lot Number: 6970383
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 85