MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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.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) 2017, a patient underwent removal of the left radial head prosthesis due to loosening that caused osteolysis surrounding the implant.The lateral approach was used for exposure of the radial head and a lateral incision was made.Dissection was taken down through the skin and subcutaneous tissue.The plane between the ecu and aconeus was identified.The capsule was incised longitudinally, avoiding damage to the lateral collateral ligament.The radial head was then identified, and radial head arthroplasty was removed using a kocher with ease.The area was irrigated copiously with normal saline after the arthroplasty was removed.On (b)(6) 2015, the patient slipped and fell in a parking garage and landed onto her left elbow.The patient had immediate pain and deformity of the left elbow and inability to bear weight.The patient sustained a traumatic left elbow fracture-dislocation with associated comminuted radial head, lateral collateral ligament avulsion and anterior capsular injury.Upon consultation on (b)(6) 2015, the patient had swelling, ecchymosis and tenderness to palpation at the medial and lateral aspects of the elbow in the left upper extremity.The patient was unable to tolerate flexion and extension of the elbow secondary to pain, unable to abduct and forward flexion.On (b)(6) 2015, the patient underwent an open left radial head replacement of the left elbow, left lateral collateral ligament (lateral ulnar collateral ligament repair of the left elbow), left anterior capsule repair and removal of loose bodies of the left elbow.The patient was implanted with a synthes radial head prosthesis.On (b)(6) 2016, upon clinic visit, the patient still had some weakness with wrist dorsiflexion in trying to extend the fingers.The x-ray result on (b)(6) 2016 revealed evidence of radiolucency adjacent to the stem of the radial head replacement.On (b)(6) 2016, upon the patient¿s clinic visit, the patient reported that she had been developing increasing left-sided wrist pain that radiated up to the forearm over the last month or so, as well as some significant (increasing) pain at the palmar aspect of the left thumb proximal phalanx.An x-ray of the left elbow showed a significant amount of osteolysis adjacent.X-ray of the left wrist showed evidence of mildly malaligned fracture with some mild shortening of roughly 2mm of the distal radius.On (b)(6) 2017, the patient went on a clinic visit and reported that she noticed some increased pain on both the medial and lateral aspect of the left elbow as well as some pain radiating to the wrist about a few weeks ago.The patient had tenderness on palpation at the cubital tunnel, and a positive tinel sign.There was also some mild pain at the lateral aspect of the left distal humerus as well at the radiocapitellar joint.An x-ray revealed a significant osteolysis adjacent to the stem of the prosthesis as well as along both the canal and the neck of the radius.On (b)(6) 2017, upon clinic visit, it was noted that the patient was developing some evidence of proximal radial osteolysis, which was first noted in (b)(6) 2016.This report is for one (1) radial head prosthesis radial stem.This is report 2 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.Added electrocardiogram date (b)(6) 2015.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

After the initial implant procedure, the patient underwent physical therapy.On (b)(6) 2017 the patient had a clinic visit and it was decided to go ahead with the revision procedure to remove the radial head implant.The patient also was treated for her right trigger thumb during that visit.On (b)(6) 2017 the patient had a follow up visit after the revision procedure.It was noted, she was doing well and had been doing rom exercises with the left elbow.She had no complaints of pain.On (b)(6) 2017 the patient had a follow up visit.It was recommended the patient begin physical therapy.It was noted the patient was doing well with only normal post-operative weakness.On (b)(6) 2017 the patient had a follow up visit.It was noted the patient had been experiencing pain.The patient¿s physical therapy was completed, and she was doing at home exercises.It was determined at this appointment, no treatment for the pain would be administered.On (b)(6) 2017 the patient had a follow up visit.The patient was still experiencing pain.The patient experienced some pain relief with at home exercises.Csi was administered during the visit to address the pain.On (b)(6) 2017 the patient had a follow up visit.It was noted the patient and surgeon were happy with the patient¿s progress.The patient will continue working on motion and strengthening.

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.Visual inspection of the provided images showed no issues of stem loosening.This complaint was not confirmed based on the review of received x-rays.Based on the images, no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Relevant actions have been taken to address the previously known issues.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.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.

• 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: 8390444
• MDR Text Key: 137835885
• Report Number: 2939274-2019-56802
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 78