MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number 09.402.020S

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Discomfort (2330); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).

Event Description

This report is against user facility medwatch number (b)(4).The only information contained in this report is correction or additional information.It was reported by the facility that medwatch (b)(4) has been submitted to the fda on june 7, 2018.The reported patient was a (b)(6) female that underwent removal of right radius and ulna implant & hardware on (b)(6) 2018 due to progressive loosening of the implant and osteolysis around the other metal in her elbow.The patient complained of clicking and discomfort.The original implant date (b)(6) 2015.Explanted (b)(6) 2018.Intra-operative, the intraosseous cystic lesion in the olecranon was filled with demineralized bone matrix.The radial head system and hardware had been implanted on (b)(6) 2015, for right elbow fracture-dislocation requiring redial head arthroplasty.Following an uneventful, course, the patient was discharged home on (b)(6) 2018.As of (b)(6) 2018, post-operative office visit: no acute distress.Incision sites clean dry and intact.Without evidence of infection.Sutures removed.Passive range of motion through right elbow 10 degrees in extension to 110 degrees of flexion, supination 30-degree, pronation 60 degrees.The contralateral side has supination which lacks 5 degrees, otherwise full.Sensory and motor function is intact bilateral supper extremities, soft compartments, 2+ pulses present.To begin physical therapy for active and passive range of motion through the right elbow to focus on flexion, extension, pronation, and supination activities.Five-pound maximum lifting restriction.T return in 4 to 5 weeks for repeat evaluation with x-rays.The patient will be weaned off the sling as tolerated.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.Device 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.(b)(4).

• Brand Name: 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-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: 7659821
• MDR Text Key: 113161224
• Report Number: 2939274-2018-52706
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132581
• UDI-Public: (01)10886982132581
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 09.402.020S
• Device Catalogue Number: 09.402.020S
• Device Lot Number: 7838260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2018
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention