MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 04.402.027S

Device Problem Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Date of event is an unknown date in 2017.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.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.A device history record review has been requested.(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) 2017, the patient underwent removal of radial head implant, open reduction internal fixation (orif) of periprosthetic left proximal radius fracture nonunion, and bone grafting of left proximal radius fracture with allograft due to a loose left radial head implant with periprosthetic proximal radius fracture.The radial head implant was identified and noted to be very loose.The coupling screw between the head and the stem was removed and the head was explanted.The stem was then easily explanted as well.A partially threaded synthes 6.5mm cannulated screw with a synthes washer was then used and placed over the guidewire.There were no signs of infections.There was excellent compression of the fracture site with appropriate cannulated screw placement and length.Originally, the patient was implanted with 22mm radial head prosthesis on (b)(6) 2016, during radial head arthroplasty due to radial neck fracture malunion.On (b)(6) 2017, the patient went to the clinic for a postoperative visit and stated that the symptoms worsened compared to the preoperative symptoms.The patient had shown a decrease in activity level.Incision was well healed without signs of infections.Full elbow motion could be achieved without pain.Radiography of left elbow, 2 views demonstrated stable radial head arthroplasty with some radiolucency around the stem.On (b)(6) 2017, the patient went to the clinic with complaints of severe pain on the left elbow and felt very weak.The patient felt a pop and had instant pain during workout.Diffuse mild swelling about the elbow was noticed upon inspection and diffuse tenderness about the elbow, especially overlying the fracture site upon palpation.The patient was not able to test motion and strength due to pain and fracture.The patient was instructed to wear fabricated splint from ot full time for 4 weeks.Radiographs on (b)(6) 2017, showed significant osteolysis around the radial head arthroplasty implant and fracture line extending near the tip of the implant anteriorly through the cortex, as well as posteriorly through the cortex just proximal to the tip of the implant.Radiographs on (b)(6) 2017, continued to show a loose long stem radial head implant with significant osteolysis around the implant.The fracture at the tip of the implant was unchanged, there may have been some interval callus formation anteriorly.On (b)(6) 2017, the patient went to the clinic for follow up visit of left proximal radius fracture (periprosthetic fracture at the tip of loose long stem radial arthroplasty with osteolysis surrounding the implant) and stated that symptoms were improving since the last appointment.Patient denies any numbness and tingling.Near full motion, however, felt pain at terminal flexion, extension, supination, and pronation.The patient elected to proceed with surgery consisting of hardware removal, orif of proximal radius and possible autologous bone grafting.On (b)(6) 2017, the patient went to the clinic for follow up visit of left proximal radius fracture.The patient was scheduled for left radial head hardware removal and possible revision of radial head arthroplasty.Radiography showed diffuse osteopenia and evidence of fracture of the proximal radius over the distal portion of the stem.There was periprosthetic lucency over the bone with marked narrowing of the cortex over the posterior buttress region, which is unchanged on the previous study.There appears to be a tiny amount of periosteal reaction noted over the anterior portion on the lateral view.The medial buttress appears to be markedly narrowed on the ap view.Periosteal reaction was noted over the lateral cortex over the distal portion of the stem, which appears increased when compared to the previous study.The periprostatic osteopenia has increased since the previous exam.Current patient status is unknown.This report is for a 7mm titanium (ti) curved radial stem 42mm.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.H10 additional narrative: h3, h4, h6.Device history lot, release to warehouse date: 03-may-2016, expiration date: 31-mar-2021, part number: 04.402.027s, 7mm ti curved radial stem 42mm ¿ sterile, lot number: h091256 (sterile).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.Additional data- d4, b7, h4.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: 7MM TI CURVED RADIAL STEM 42MM-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: 8129617
• MDR Text Key: 129219719
• Report Number: 2939274-2018-55253
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096
• 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,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: H091256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2018
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR