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

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Arthritis (1723); Pain (1994); No Code Available (3191)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.This report is for an unknown radial head prosthesis:r/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).The investigation could not be completed; no conclusion could be drawn.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, the patient had a left elbow radial head and bone grafting due to pain and loose radial head implant with a recalled synthes radial head replacement.They carried out dissection down to the fascia in kaplan's interval, come directly upon the radial head implant and removed it with two fingers.Thoroughly irrigated the joint to remove any loose fragments.Originally, the patient had an open reduction internal fixation (orif) of left coronoid fracture, left radial head replacement and left ulnar collateral ligament repair.Was implanted with an unknown radial head on (b)(6) 2016, due to left terrible triad elbow fracture-dislocation when she was pulled down some stairs by the patient's dog.On (b)(6) 2016, after seven weeks out from injury.The patient having some pain in the lateral aspect of the elbow and forearm which is worse when she get extremes of motion, working on her elbow range of motion exercises.On (b)(6) 2016, after 3 months follow-up, the patients notes her range of motion in the forearm and the elbow has been improving, but her pain is essentially the same as it has been since six weeks ago.It got worse with activity and better with rest.The pain is primarily on the lateral aspect of the elbow and sometimes extends down the forearm on the lateral side.It is worse on the dorsal than on the volar side of the forearm.On (b)(6) 2016, the patient began having some pain and instability type of symptoms.A posterior lateral rotatory drawer under fluoroscopy confirmed incompetent lateral ulnar collateral ligament.Of note, she does have some hypersensitivity around the scar.The patient had developed some hair growth posteriorly in addition to that, and some color changes of her left upper extremity, consistent with complex regional pain syndrome.On (b)(6) 2016, had a lateral ulnar collateral ligament insufficiency which leads to left elbow lateral ulnar collateral ligament reconstruction.On august 15, 2017, the patient experience increase in pain which is located over the forearm, and she has difficulty with the arm.It at times will get stuck and is very painful to the patient.Imaging studies show that the x-ray result shows a markedly loose radial head implant.On (b)(6) 2016, the patient experience an onset of the left upper extremity pain.The patient endorses a patchy area of hair growth near the left elbow.Has sensitivity to temperature changes of the left upper extremity.Has swelling immediately following her surgeries of the left upper extremity.Concomitant device reported: tendon,plantaris: (part #: 2315-14, lot #: 46-3623 160672-025, quantity #: 1).This complaint involves two (2) devices.This report is for one (1) unk - radial head prosthesis: radial stem.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.Date of event: exact date of postoperative radial head prosthesis loosening is unknown.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.Investigation summary: product code: unk - radial stem, lot #: unknown, quantity: 1 actual device was not returned; us customer quality will conduct investigation based on the x-rays provided.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 performed at customer quality on the device images provided showed no issues of stem loosening.The x-rays (2 images) were reviewed, the complaint was not able to be confirmed by us cq.However, there are known issues with the radial head implants.There is also a recall that was initiated as part of field action investigation.Dhr review is not possible with unknown lot conclusion: 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 (based on the images) that may have contributed to the complaint condition.However, based on previous complaints, the radial head prosthesis system (rhp system) was recalled under recall# 555531.Any related investigations and assessment of the risks associated with this system will be covered under recall and hhe investigations.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.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.This report is for an unknown radial stem/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Reporter is patient's 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.

• 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: 8423184
• MDR Text Key: 138892857
• Report Number: 2939274-2019-56983
• 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
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• 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: 04/05/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 111