MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Catalog Number 04.402.008S

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Report is for an unknown radial head stem/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is patient.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 an unknown date, the patient experienced pain and discomfort prior to and after explantation of a radial head stem.Patient continues to experience ongoing pain and discomfort and limited use of the right arm.On (b)(6) 2016, the patient fell and sustained a right elbow radial fracture and dislocation of her elbow and torn ligaments.On (b)(6) 2016, the patient underwent an procedure to implant a depuy synthes radial head prosthesis system.On (b)(6) 2018, an x-ray of the patient's right elbow was taken which reflected that the radial head of the synthes implant had become loose causing the synthes implant to impact and grind on the round end of the humerus bone causing pain and discomfort and functional limitations.On (b)(6) 2018, the patient underwent another procedure to remove the synthes implant which has not yet been replaced leaving the patient without a radial head on her elbow.Concomitant devices: unknown radial head (part # unknown, lot # unknown, qty 1).This is report 1 of 1 for (b)(4).This report is for an unknown radial head stem.

Event Description

Updated event description: it was reported that on an unknown date, the patient experienced pain and discomfort prior to and after explantation of a radial head stem.Patient continues to experience ongoing pain and discomfort and limited use of the right arm.On (b)(6) 2016, the patient fell and sustained a right elbow radial fracture and dislocation of her elbow and torn ligaments.On (b)(6) 2016, the patient underwent an procedure to implant a depuy synthes radial head prosthesis system.On (b)(6) 2018, an x-ray of the patient's right elbow was taken which reflected that the radial head of the synthes implant had become loose causing the synthes implant to impact and grind on the round end of the humerus bone causing pain and discomfort and functional limitations.On (b)(6) 2018, the patient underwent another procedure to remove the synthes implant which has not yet been replaced leaving the patient without a radial head on her elbow.On (b)(6) 2018, the patient reports that she has intermittent swelling and numbness around the surgical site.She also reports a "cracking" sensation around her right elbow and is taking medicine for nerve pain.On (b)(6) 2018, the patient reports that she feels to be improving significantly with regard to her pain and range of motion.

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.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.

Manufacturer Narrative

Product complaint # (b)(4).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.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.

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.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1-a4 patients height reported as (b)(6).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.

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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) were reviewed, and the complaint condition could not be confirmed as the images did not conclusively display any device related issues.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 product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot manufacturing location: supplier - (b)(4), packaged and released by: monument, manufacturing date: jul 24, 2014, expiration date: jun 30, 2019, part number: 04.402.008s, 8mm ti straight radial stem 28mm ¿ sterile, lot number: 7608053 (sterile), lot quantity: 146.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 27-jun-2014 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, ns050779 rev b met all inspection acceptance criteria.Packaging label logs lppf, lmd/lpf rev a were reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 10436 supplied by sterigenics was reviewed and determined to be conforming.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: 21014, tialnbri16.00, lot number: 6190711, lot quantity: 2,335 lbs.Product traveler met all inspection acceptance criteria.Product certification supplied by dynamet dated jul 17, 2009 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: 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.

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.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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9916717
• MDR Text Key: 186552485
• Report Number: 2939274-2020-01675
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7608053
• Date Manufacturer Received: 10/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 84