MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Catalog Number 09.402.020S

Device Problem Unintended Movement (3026)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - radial head prosthesis/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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

It was reported that on an unknown date, the patient underwent an unknown surgery due to an implant that was subsequently loosened and was ultimately removed and revised.On an unknown date, the patient received the radial head prosthesis implant following a fall.The procedure and patient outcome were unknown.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

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.H3, h4, h6: manufacturing location: supplier - (b)(4) / inspected, packaged and released by: monument release to warehouse date: january 28, 2016, expiration date: december 31, 2020, part number: 09.402.020s, 20mm cocr radial head standard height/12.0mm ¿ sterile, lot number: h021034 (sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated january 7, 2016 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual 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: 21022, tialnbri8.00, lot number: 5345317, lot quantity: 4,257 lbs.Product traveler met all inspection acceptance criteria.Raw material inspection sheet met all inspection acceptance criteria.Certified test report supplied by (b)(4) dated september 18, 2006 and inspection certificate supplied by (b)(4)dated april 10, 2006 were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41060, cocrmori25.40, lot number: 9804004, lot quantity: (b)(4).Certificate of tests supplied by (b)(4) dated april 15, 2015 was reviewed and determined to be conforming.Lot summary report dated april 30, 2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 a revision left radial head arthroplasty due to left failed radial head arthroplasty.She developed osteolysis of the implant.The implant was noted to have been recalled after its placement.There was a note to be a moderate amount of synovitis within the joint.The implant was noted to be loose and the implant was subsequently removed.On (b)(6) 2016, the patient underwent a closed reduction left fracture-dislocation of the elbow due to fracture dislocation left elbow, radial head fracture w/ lateral epicondyle fracture, and dislocation of the elbow joint.On (b)(6) 2016, the patient who is a s/p fracture-dislocation of her left elbow and had a highly comminuted radial head fracture underwent a left elbow radial head arthroplasty with lateral ulnar collateral ligament repair.On (b)(6) 2018, the patient had a follow-up visit and claims to have stiffness issues postoperatively, reports pain in the lateral elbow but attends extensive therapy.Concomitant devices reported: 7mm ti straight radial stem 26mm-sterile (part number 04.402.007s, lot 7855594, quantity 1).This report involves one (1) 20mm cocr radial head standard height/12.0mm-sterile.This is report 1 of 2 for (b)(4).

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: 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: 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: 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-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: 10006010
• MDR Text Key: 189767751
• Report Number: 2939274-2020-02080
• 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
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 09.402.020S
• Device Lot Number: H021034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: 7MM TI STRAIGHT RADIAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Weight: 62