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 Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Loss of Range of Motion (2032); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Patient date of birth/age, and weight were not provided for reporting.Date of event is unknown.This report is for one (1) unknown radial head prosthesis.Part#, lot# and udi # is not available.Date of implant is unknown.It is unknown if patient underwent explant procedure.Date of explant is not applicable/unknown.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown radial head prosthesis.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 there is a complaint regarding the radial head prosthesis system.Patient had accident on (b)(6) 2016.Patient outcome was not reported.This report is for one (1) unknown radial head prosthesis.This is report 1 of 2 for (b)(4).

Event Description

It was reported that on (b)(6) 2019, the patient reports left elbow pain that radiates down to her wrist joint.She also states that she has had residual stiffness and pain since the surgery and now hoping someone may be able to improve her function with pain stated to have been worsening over the past year.She has been cleared for her cervical cancer and can proceed with hardware removal surgery of her left radial head arthroplasty.On (b)(6) 2016, the patient fell off a platform onto her outstretched left upper extremity.She sustained an apparent left elbow radial head fracture.On (b)(6) 2016, the patient broke her wrist when she missed a step and fell.She noted numbness and tingling in her arm, forearm, and hand.On (b)(6) 2016, the patient underwent left radial head replacement due to a radial head fracture.It was noted that the radial head had several fracture lines and plastic deformation rendering it unreconstructable.At this point, the decision was made to proceed w/ radial head replacement instead of an open reduction internal fixation.On (b)(6) 2018, a patient who was being treated for endometrial cancer, presented for a consultation regarding her left upper extremity.She stated that she had found out that the radial head implant has been recalled as it was led to loosening.She never regained full range of motion and has difficulty extending her elbow, but also has trouble with pronation and supination.She has left forearm pain that radiates down to the ulnar aspect of her wrist and she notes that the appearance of her ulnar head is different than the contralateral side.She has constant severe, throbbing, and aching pain in her left upper extremity, which can reach a 6/10 with certain activities.She feels she has lost strength in her upper extremity.Her symptoms wake her up at night.She does get occasional numbness and tingling in her left upper extremity.The patient was diagnosed with a left elbow flexion contracture along with left forearm pronation and supination contracture.She also felt to have a possible left forearm essex lopresti injury.Mild subsidence of the radius was noted.

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.H10 additional narrative: d8: it is unknown whether this single-use device was reprocessed and reused.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: updated data-a1, a2, b5, b6, h6.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, a patient who is currently being treated for endometrial cancer, presented for a consultation regarding her left upper extremity.She stated that she had found out that the radial head implant has been recalled as it was led to loosening.She never regained full range of motion and has difficulty extending her elbow, but also has trouble with pronation and supination.She has left forearm pain that radiates down to the ulnar aspect of her wrist and she notes that the appearance of her ulnar head is different than the contralateral side.She has constant severe, throbbing and aching pain in her left upper extremity, which can reach a 6/10 with certain activities.She feels she has lost strength in her upper extremity.Her symptoms wake her up at night.She does get occasional numbness and tingling in her left upper extremity.On (b)(6) 2016, the patient fell off a platform onto her outstretched left upper extremity.She sustained an apparent left elbow radial head fracture.On an unknown date, the patient underwent open reduction of her fracture with placement of a titanium radial head implant.

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, manufacturing date: 07-jun-2016, expiration date: 30-apr-2021, part number: 09.402.024s, 24mm cocr radial head standard height/13mm ¿ sterile, lot number: h112404 (sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 19-may-2016 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 12610 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: 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 18-sep-2006 and inspection certificate dated 10-apr-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 dated 15-apr-2015 was reviewed and determined to be conforming.Lot summary report dated 30-apr-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/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.

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.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.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) 2020, the patient underwent a removal of left radial head arthroplasty procedure.On an unknown date, the patient has been doing well since surgery.Pain is moderately controlled on the current pain regimen and was able to complete her physical therapy.She complains of pain with therapy and the stretches they did to help with her valgus deformity.She also stated that she has intermittent numbness to her left 4th and 5th fingers with an associated dropping her phone on several occasions.The patient is left hand dominant.On (b)(6) 2020, the patient presented weakness in the left-hand clawing of digits 4 and 5 noticed after a non-displaced fracture of the radial head with delayed healing and an acquired valgus deformity of the left elbow.Since then she has noted numbness in digits 4 and 5 and weakness of the left hand with weak grip strength.

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: 7542514
• MDR Text Key: 109238236
• Report Number: 2939274-2018-52310
• 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: company representative,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 09.402.024S
• Device Lot Number: H112404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Age: 33 YR