MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number 09.402.024S

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

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Expiration date unknown, lot unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.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 conclusion could be drawn at the time of filing this report.Investigation summary: 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) 2016, the patient underwent a right elbow radial head replacement with depuy synthes radial head prosthesis system.On or about (b)(6) 2018, the patient underwent a removal and replacement of the radial head system due to loosening.This complaint involves two (2) devices.This report is for one (1) 24 mm cocr radial head standard height/13.0 mm-sterile.This report is 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.H6: patient code 3191 used to capture additional medical/surgical intervention required.E3: reporter is attorney.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.Manufacturing location: supplier - (b)(4) / inspected, packaged and released by: monument.Manufacturing date: 07-apr-2015.Expiration date: 28-feb-2020.Part number: 09.402.024s, 24mm cocr radial head standard height/13.0mm ¿ sterile lot number: 7855835 (sterile).Lot quantity: 25.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated (b)(6) 2015 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 11181 supplied by sterigenics was reviewed and determined to be conforming.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: (b)(4).Product traveler met all inspection acceptance criteria.Raw material inspection sheet met all inspection acceptance criteria.Certified test report supplied by perryman company dated (b)(6) 2006 and inspection certificate supplied by vsmpo dated (b)(6) 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: 7695678.Lot quantity: 976 lbs.Certificate of tests supplied by carpenter dated (b)(6) 2014 was reviewed and determined to be conforming.Lot summary report dated (b)(6) 2014 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.H6: code 3191 used to capture surgical intervention and medical device removal.

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 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: 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-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: 9477133
• MDR Text Key: 171539553
• Report Number: 2939274-2019-62685
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132604
• UDI-Public: (01)10886982132604
• 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: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 09.402.024S
• Device Catalogue Number: 09.402.024S
• Device Lot Number: 7855835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 88