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 Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Hypoesthesia (2352); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) the complaint indicated that the patient had post-op pain, numbness, tingling and implant loosening which required additional surgical intervention.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.

Event Description

It was reported that on (b)(6) 2017, the patient underwent removal of radial head implant, revision of head arthroplasty with lateral collateral ligament repair and elbow synovectomy due to implant loosening.The timeline of events is following: on (b)(6) 2016, patient went to the er department with complaints of left arm pain.X-rays were taken, and splint was applied.A fracture was identified upon elbow x-ray.On (b)(6) 2016, the patient underwent prosthetic replacement of left radial using unknown synthes prosthetic radial head with a long pressfit stem size 7 and a size 22 +0 head due to left radial head fracture.From (b)(6) 2017 to (b)(6) 2017, the patient returned to the clinic with complaints of chronic pain in the left wrist and left upper shoulder pain.The patient felt pain in the distal forearm and distal radioulnar joint (druj).The pain got worst with activity and better with rest.The patient felt some vague numbness and tingling in the arm.The patient tried a brace, hear, ice, over the counter creams and non-steroidal anti-inflammatories but without sufficient relief.Druj injection also did not provide relief.Elbow x-ray, 5 views was taken on (b)(6) 2017 and demonstrated a congruent elbow joint with radial head implant arthroplasty with some lucency that developed around the stem of the radial head implant indicative of loosening.On (b)(6) 2017, the patient underwent removal of radial head implant, revision of head arthroplasty with lateral collateral ligament repair and elbow synovectomy due to loosening.A non-synthes device was used.Careful blunt dissection was performed through the subcutaneous tissues with tenotomy scissors.The midpoint of the capitellum was identified and the fascia of the extensor was incised longitudinally just anterior to the midpoint of the capitellum to preserve the lateral ulnar collateral ligament and its insertion.A longitudinally arthrotomy was made sharply.There was a significant amount of serous inflammatory fluid present.There was extensive synovitis as well and a synovectomy was performed with a rongeur and tissue was sent for routine culture.The implant was grossly loose and was easily removed.Final components were selected and opened.The stem was inserted with excellent fit.The head was placed followed by the set screw.The elbow was taken through range of motion and noted to have full range of motion.The joint was copiously irrigated.The patient was then taken to pacu in good condition this complaint involves one (1) devices.This report is 1 of 1 for.

Manufacturer Narrative

Device history lot manufacturing location: supplier - (b)(4) inspected, packaged and released by: (b)(4).Manufacturing date: 26-nov-2014.Expiration date: 31-oct-2019.Part number: 04.402.027s, 7mm ti curved radial stem 42mm ¿ sterile.Lot number: 7785170 (sterile).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.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

Concomitant devices: radial head (part: 09.402.022s, lot: h032035, quantity: 1).

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: 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: 8135710
• MDR Text Key: 129434800
• Report Number: 2939274-2018-55305
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7785170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2019
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR