MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 04.402.008S

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

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.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 due to loosening with lucency in the bone surrounding the stem portion of the radial head.An incision was made going through the scar on the lateral side of the elbow.This was taken sharply through the skin and subcutaneous tissue.The joint capsule was divided longitudinally as well exposing the radial head.There was an only small amount of serous fluid within the elbow joint.Then the soft tissue was debrided from around the neck region exposing the radial head.This was loosened up; the surgeon was able to grasp the radial head implant and moved it in one piece.There is no obvious infection present.There was not a significant amount of soft tissue reaction within the bone.The patient tolerated the procedure well and there were no intraoperative complications.On (b)(6) 2015, the patient went to the clinic with sustained elbow fracture-dislocation due to fall.Elbow x-ray showed dislocation of the left elbow with a comminuted fracture of the radial head.On (b)(6) 2015, the patient was implanted with synthes 26mm +0 chrome cobalt radial head and 8mm x 28mm straight stem during radial head arthroplasty and repair of lateral collateral ligament using fluoroscopy due to fracture dislocation of the left elbow with radial head.On (b)(6) 2017, the patient noticed some aching in his arm after he had exercises.On (b)(6) 2017, the patient went to the clinic with complaints of diffuse soreness around but had no acute changes for the worse.Elbow x-ray showed radial implant had loosened neck and there was significant lysis around.Concomitant device reported: radial head (part#09.402.026s, lot#6892270, quantity#1).This report is for one (1) 8mm ti straight radial stem 28mm-sterile.This is report 1 of 1 for (b)(4).

Event Description

It was reported that on (b)(6) 2017, the patient underwent removal of radial head implant due to loosening with lucency in the bone surrounding the stem portion of the radial head.The surgeon was able to grasp the radial head implant and remove it in one piece.There was no obvious infection present.There was not a significant amount of soft tissue reaction within the bone.The patient tolerated the procedure well and there were no intraoperative complications.On (b)(6) 2015, the patient went to the clinic with sustained elbow fracture dislocation due to fall.Elbow x-ray showed dislocation of the left elbow with comminuted fracture of the radial head.On (b)(6) 2015, the patient was implanted with synthes 26mm +0 chrome cobalt radial head and 8mm x 28mm straight stem during radial head arthroplasty and repair of lateral collateral ligament using fluoroscopy due to fracture dislocation of the left elbow with radial head.On (b)(6) 2015, the patient still had a fair amount of swelling in the elbow.Pronation and supination were very limited.On (b)(6) 2015, the patient had some mild swelling around the elbow.X-ray result showed a minimal amount of calcification.On (b)(6) 2015, the patient noticed some aching in the arm, particularly in the forearm exercises.On (b)(6) 2017, the patient went to the clinic with complaints of diffuse soreness but had no acute changes for the worse.Elbow x-ray showed the radial implant had a loosened neck and significant lysis.Concomitant devices: radial head implant (part: 09.402.026s, lot: 6892270, quantity: 1).This report is for one (1) 8mm ti straight radial stem 28mm-sterile.This is report 1 of 1 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.Manufacturing location: supplier - avalign nemcomed / inspected; packaged and released by: monument; manufacturing date: november 20, 2014; expiration date: october 31, 2019; part: 04.402.008s; 8mm ti straight radial stem 28mm ¿ sterile; lot: 7683417 (sterile); lot quantity: 148.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from alalign was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 10787 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part: 21014, tialnbri16.00; lot: 7557656; lot quantity: 3,059 lbs.Certified test report supplied by perryman company and inspection certificate supplied by vsmpo were reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.The device was not returned for physical evaluation.The following investigation is based on review of the provided medical imaging.Device evaluation: investigation type: picture investigation the device in the provided medical imaging appears intact with no visual defects.The first image reveals x-ray taken on the day the device was first implanted.Whereas, the remaining images are records of x-rays taken on unknown dates.However, upon comparison, it appears that there is a gap between the radial head implant and bone which is consistent with loosening.Thus, the complaint condition is conservatively considered confirmed.No definitive root cause was able to be determined.For this complaint, no design or manufacturing issues were observed.However, the radial head prosthesis system (rhp system) was recalled under z-1124-2017.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Relevant actions have been taken to address the issue.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument.Manufacturing date: 20-nov-2014.Expiration date: 31-oct-2019.Part number: 04.402.008s, 8mm ti straight radial stem 28mm ¿ sterile.Lot number: 7683417 (sterile).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21014, tialnbri16.00.Lot number: 7557656.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.

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-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: 8130614
• MDR Text Key: 129302478
• Report Number: 2939274-2018-55257
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128058
• UDI-Public: (01)10886982128058
• 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
• 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: 10/31/2019
• Device Model Number: 04.402.008S
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7683417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 118