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 Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Additional patient¿s identifier reported as: (b)(6).Patient¿s weight is unknown.Date of event: date of postoperative radial stem loosening is unknown.Explanted date: not explanted.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.

Event Description

It was reported that a patient is experiencing symptoms of advancing osteolysis (bone degeneration around the implant) after a radial head prosthesis implant on (b)(6) 2016.An x-ray taken on an unknown date shows the stem of the implant appears to be loosening.A revision surgery has not yet been scheduled.This report is for one (1) 7mm ti curved radial stem 42mm-sterile.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

A device history record (dhr) review was performed for part #: 04.402.027s, lot#: 7855651: manufacturing location: (b)(4), packaged by: (b)(4), manufacturing date: 06-apr-2015, expiration date: 28-feb-2020: part #: 04.402.027s, lot#: 7855651 (sterile) - 7 mm ti curved radial stem 42mm-sterile.Quantity 24.Raw material part no: 21069 lot number- 7506606 reviewed.Inspection sheet for incoming final inspection meet inspection criteria.Certificate of compliance from (b)(4) for (b)(4) meet specification.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.¿ 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

Additional narrative: patient height reported as 5 feet 11 inches.Corrected data: patient age at time of event (procedure) was (b)(6) as previously reported.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

Updated/ clarified timeline of events: on (b)(6) 2016 - date of injury - (b)(6) hospital emergency department - it was reported patient presented with left arm pain, following a fall/ trip on a step, landing on the arm.Left elbow x-rays were taken on (b)(6) 2016, and findings showed a comminuted displaced fracture of the radial head, extending to the radiocapitellar joint.The fracture is impacted, the radiocapitellar joint is mildly subluxed.Patient was prescribed acetominophen/ hydrocodone with bitart (norco) and ibuprofen, and discharged to home.On (b)(6) 2016- return to clinic - (b)(6) hospital orthopedic department.History and physical exam evaluation.Patient noted numbness, pain (6/10) and tingling in arm, forearm, and hand.Patient was diagnosed with left displaced radial head fracture.Laboratory tests and x-rays were completed on (b)(6) 2016.Open reduction and internal fixation vs.Radial head replacement was discussed.Patient was given a splint to provide stability of the injury.On (b)(6) 2016 - patient presented to (b)(6) medical center reporting pain 7/10, and that splint is uncomfortable and poking in certain areas.Patient is out of pain medications.Patient diagnosed with left radial neck fracture, and was prescribed norco.There is no new injury, and an orthopedic appointment is scheduled for next week.On (b)(6) 2016 - patient underwent surgical procedure at (b)(6) medical center.Preoperative diagnosis: left radial head fracture.Postoperative diagnosis: left comminuted five-part radial head fracture.During the procedure it was noted that the radial head had several fracture lines and plastic deformation, making it unreconstructable.At this point the decision was made to proceed with radial head replacement instead of an open reduction internal fixation.Components were placed and forearm rotation was assessed and found to be within functional limits.Components placement was also evaluated on intraoperative fluoroscopy which showed no gapping of the ulnohumeral joint, the procedure was completed, wound was closed and dressed, and the patient was placed in a hinged elbow brace with 30 degrees locked to full extension.Postoperative plan includes full flexion, and 30 degrees short of full extension for 3 weeks with occupational therapy.This to be followed by beginning supination and pronation as tolerated with the elbow kept at 90 degrees of flexion.No weight bearing on upper left extremity until after postoperative assessment in clinic.Left elbow radiographs will be planned at 6 weeks.On (b)(6) 2016 - patient returned to (b)(6) medical center for post-injury/ post-operative clinic for follow-up of comminuted five-part radial head fracture and radial head replacement.The wound was redressed, and patient to continue occupational therapy.There were no reported radiographs taken at this followup.On (b)(6) 2017 - patient returned to (b)(6) medical center for post-injury/ post-operative clinic for follow-up of comminuted five-part radial head fracture and radial head replacement.Patient reported pain level of 8/10.X-rays taken on (b)(6) 2017 revealed stable alignment of the left radial head prosthesis.The is no acute fracture or dislocation.Patient has an acceptable range of motion, but continues to have pain in the left elbow and wrist.Occupational therapy to be continued.Surgeon's opinion is that the pain is likely related to loose prosthesis with proximal migration of the distal radius at the radial ulnar joint, as per x-rays of (b)(6) 2017.Surgeon recommends replacement of prosthesis.On (b)(6) 2017 - patient presents to orthopedic surgeon (dr.(b)(6)) for the purpose of an independent medical evaluation for the (b)(6) division of workers' compensation including medical history review, examination, review of records/ diagnostic studies, and range of motion testing and report.Patient complains of constant pain in the left elbow.Any activity or repetitive motion aggravates the symptoms.Extension increases pain in the elbow, resting the arm reduces the pain.Examination reveal there are no deformities swelling, atrophy, skin discoloration or scars noted.The patient does not present utilizing any braces at this time.Neurological sensations are within normal limits, and pulses are intact.X-rays show a metallic radial head prosthesis with a stem.The independent surgeon's evaluation indicates that there is 'sort of a windshield wiper effect' that would suggest that there is some loosening of the prosthesis.Also, that the ulnar positive to ulnar neutral configuration on the left which would indicate some proximal migration of the radius when comparing to the right side.No further records were provided to the independent evaluator after the postoperative follow-up appointment at (b)(6) medical center on (b)(6) 2017.On (b)(6) 2018 - at this time the patient has not undergone any repair or replacement surgeries regarding the radial head implant.

Manufacturer Narrative

Device history record (dhr) review: manufacturing location: supplier (b)(4), packaged by: (b)(4); manufacturing date: april 06, 2015; expiration date: february 28, 2020; part #: 04.402.027s, lot#: 7855651 (sterile) - 7 mm ti curved radial stem 42mm-sterile; quantity (b)(4).Raw material part no: 21069 lot number- 7506606 reviewed.Inspection sheet for incoming final inspection meet inspection criteria.Certificate of compliance from avalign (nemcomed) for titanium meet specification.No nonconformance records (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterilization control number (scn) no: 11173 by sterigenics (corona).¿sterility documentation was reviewed and determined to be conforming.¿ no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary: it was reported that a patient is experiencing symptoms of advancing osteolysis (bone degeneration around the implant) after a radial head prosthesis implant on (b)(6) 2016.An x-ray taken on an unknown date shows the stem of the implant appears to be loosening.A revision surgery has not yet been scheduled.Patient has contacted an attorney regarding this implant and it is expected that the attorney will contact j & j law department.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# 555531 and field action investigations.Since the radial head prosthesis system has been recalled and the complaint condition will be investigated through those efforts, no further investigation is required.Product was not returned.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-marketing surveillance activities.If additional information is made available the investigation will be updated as applicable.Updated 25oct2018 for investigation on provided x-rays, device not returned.The x-rays were reviewed and based on the x-rays alone us customer quality (cq) cannot confirm this complaint.However, there are known issues with the radial head implants that are captured under relevant actions.There is also a recall (recall# 555531) that was initiated as part of field action investigation where ¿device loosening¿ was identified as a high harm and contributed to the recall of the product.Based on the information from the relevant actions, us cq can confirm the complaint for loosening.Document/specification review: 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.Conclusion: the complaint condition is confirmed.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 image) that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no further corrective and/or preventative action is proposed.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

Device was used for treatment, not diagnosis.The radial head prosthesis system (rhp system) was recalled and appropriate actions have been taken to address this issue.The complaint condition will be investigated through those efforts, 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.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

Date of original injury was in (b)(6) 2016 due to a fall on a step.The patient¿s original diagnosis was left comminuted 5-part radial head fracture and treatment was reported as a left radial head arthroplasty and implant.Findings from images taken on (b)(6) 2018 state that patient appears to have some lucency surrounding the hardware.The lucency appears symmetrically around the imbedded tip of the hardware.

• 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: 7245453
• MDR Text Key: 99183559
• Report Number: 2939274-2018-50527
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096(17)200228(10)7855651
• 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,Followup,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7855651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 70