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

Catalog Number 09.402.024S

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial head prosthesis/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a synthes employee.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.(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 (b)(6) 2018, the patient underwent a revision using a non-synthes radial head prosthesis system.During the surgery, the physician(s) inspected the synthes radial head prosthesis system and determined that it had in fact loosened and was entirely unstable.There was a significant bone loss requiring a complete left elbow revision.Initially, the patient underwent surgery to repair a radial head fracture in the left arm on or about (b)(6) 2015 and was implanted with a synthes radial head prosthesis system.On or about (b)(6) 2018, the patient¿s physicians determined that the implanted synthes radial head prosthesis had loosened at the stem bone interface and recommended a revision surgery.This report is for an unknown radial head prosthesis.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.Pma/510k: awareness date reported on follow up 4 report as october 28, 2019 but should have been november 18, 2019.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

Subsequent to the surgery, the patient suffered nerve injury, loss of sensory and motor control, arthritic issues, permanent strength and control loss, and other related complications.On (b)(6) 2015, the patient fell at work and found to have ulno-humeral subluxation and radial head fracture and was placed into a splint.Complains of pain in the left elbow with numbness.On or about (b)(6) 2018, the patient¿s physicians determined that the implanted synthes radial head prosthesis loosened at the stem bone interface and recommended a revision surgery.

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.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 - avalign nemcomed / inspected, packaged and released by: monument.Manufacturing date: 10-nov-2014, expiration date: 30-sep-2019, part number: 09.402.024s, 24mm cocr radial head standard height/13.0mm ¿ sterile, lot number: 7683419 (sterile), lot quantity: 72.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 08-oct-2014 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 found to be conforming with no deviations to normal packaging identified.Scn 10763 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: 5317556, lot quantity: 956 lbs.Product traveler met all inspection acceptance criteria.Raw material inspection sheet met all inspection acceptance criteria.Product certification supplied by dynamet dated 27-sep-2006 was 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 09-may-2014 was reviewed and determined to be conforming.Lot summary report dated 20-may-2014 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.

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.

Event Description

It was reported that on (b)(6) 2018, the patient underwent a revision using a non-synthes radial head prosthesis system.During the surgery, the physician(s) inspected the synthes radial head prosthesis system and determined that it had in fact loosened and was entirely unstable.There was a significant bone loss requiring a complete left elbow revision.Subsequent to the surgery, the patient suffered nerve injury, loss of sensory and motor control, arthritic issues, permanent strength and control loss, and other related complications.On (b)(6) 2015, the patient fell at work and found to have ulno-humeral subluxation and radial head fracture and was placed into a splint.Complains of pain in the left elbow with numbness.On or about (b)(6) 2015, the patient underwent a surgery to repair a radial head fracture in the left arm and was implanted with a synthes radial head prosthesis system.Postoperatively, despite extensive physical therapy and use of brace, patient still was diagnosed with left elbow arthrofibrosis and so a manipulation under anesthesia was performed on (b)(6) 2015.On (b)(6) 2015, just about 3 months status post left radial replacement for fracture, patient complained of continued pain in his elbow, catching sensations in the elbow and wrist, and difficulty with range of motion.On (b)(6) 2016, x-rays of the left elbow showed loosening around the radial head replacement until 2018, patient's complained of left elbow stiffness, chronic pain in the left elbow, pain and weakness in the left wrist.On or about (b)(6) 2018, the patient¿s physicians determined that the implanted synthes radial head prosthesis loosened at the stem bone interface and recommended a revision surgery.This complaint involves two (2) devices.

• 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: 8371207
• MDR Text Key: 137187974
• Report Number: 2939274-2019-56676
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 09.402.024S
• Device Lot Number: 7683416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 106