MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Device Slipped (1584)

Patient Problems Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event reported as an unknown date in 2017.This report is for an unknown radial stem/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a legal professional.Without a lot number the device history records review could not be completed.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 market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(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 revision of radial head arthroplasty using a non-synthes device due to lucency along the stem of the prosthesis, likely from loosening of the implant, and had a significant osteolysis around the implant.A significant amount of scar tissue was found around the loose radial head implant.The stardrive screwdriver was used to disengage the radial head from the stem component.The synthes radial head and stem was removed.The final implant was then placed, and position was confirmed with fluoroscopy to avoid malpositioning.The elbow was taken through range of motion and found to be stable with good range of motion of the radial head.The patient was transferred to pacu in stable condition.Originally, the patient underwent radial head arthroplasty due to comminuted radial head fracture on (b)(6) 2016, and was implanted with a synthes 22mm radial head with a standard neck and number 6 stem.On (b)(6) 2016, the patient complained of some pain in the elbow, especially with motion.Radiography showed good alignment of the hardware with the reduced glenohumeral humeral joints.On (b)(6) 2016, the patient stated that her hinged-elbow brace had been loose and needed to be refitted.Radiography showed overall good alignment of the ulnohumeral and radio capitellar joints and hardware in place.On (b)(6) 2016 and (b)(6) 2016, the patient reported night sweats and weight gain of 5lbs.The patient had some limitations of motion overall but stated that the pain was well controlled.Radiography showed good alignment of the radial head and reduced ulnohumeral joint.On (b)(6) 2017, the patient went to the clinic for re-evaluation and noted some increased pain in the anterior aspect and elbow.Radiography showed congruent elbow joint with some lucency noted at the stem of the radial head arthroplasty site.On (b)(6) 2017, the patient reported some stiffness and some tingling in the fingers very intermittently.The patient felt mild distal pain with rotation of the supination and pronation.Radiography showed increased lucency at the radial head arthroplasty site.On (b)(6) 2017, the patient reported stiffness and occasional tingling in the right elbow.Patient progressed well with full return to activities and eventually returned to the clinic with increased lateral elbow pain.Right elbow radiograph showed loose radial head arthroplasty with proximal radius osteolysis and reduced elbow joint.A soft tissue anchor was present in the lateral condyle upon fluoroscopy.Surgical anchor was again noted in the lateral epicondyle upon elbow radiographs.Small elbow joint effusion was suspected.This report is for an unknown radial stem.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Visual inspection performed on the provided device images showed no issues of stem loosening.Per all the x-rays reviewed, the complaint was not able to be confirmed.However, there are known issues with the radial head implants and are captured under relevant actions.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.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.Patient id also reported as (b)(6).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.Device condition: visual inspection performed at customer quality on the device images provided showed no issues of stem loosening.Document/specification review: dhr review is not possible with unknown lot design and clinical risk management (dcrm) review: all products related to the depuy synthes radial head prosthesis system including the straight stem (part numbers: 04.402.006s-.010s) and cocr radial heads (part numbers: 09.402.018s-028s) is currently being recalled (recall# 555531) therefore all investigations related to these products are being investigated.Therefore, no further dcrm review is required at this time.Conclusion: for this compliant, no product defects were identified, and no design or manufacturing issues were observed.However, based on previous complaints, 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.Since the radial head prosthesis system has been recalled and the complaint condition was investigated through those efforts, no further investigation is required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A corrective and/or preventative action is proposed or already launched.New images received and reviewed.No new conclusions were obtained in the new images.All eleven images could not confirm the 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.

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.Date rec¿d by mfr : this date was inadvertently reported as dec 26, 2018 in the follow up report mwr-(b)(4).The correct date is dec 05, 2018.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.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 revision of radial head arthroplasty using a non-synthes device due to lucency along the stem of the prosthesis likely from loosening of the implant and had a significant osteolysis around the implant.With the forearm in full pronation, an incision was made through the fascia, through the capitellum towards the lister¿s tubercle.The dissection was extended with netzenbaum scissors.Annular ligament was similarly incised.The radial head was encountered.Dissection was carried onto the proximal aspect of the radial shaft subperiosteally.A significant amount of scar tissue was found around the loose radial head implant.The stardrive screwdriver was used to disengage the radial head from the stem component.The synthes radial head and stem was removed.The final implant was then placed, and position was confirmed with fluoroscopy to avoid malpositioning.The elbow was taken through range of motion and found to be stable with good range of motion of the radial head.The patient was transferred to pacu in stable condition.On (b)(6) 2016, the patient underwent radial head arthroplasty due to comminuted radial head fracture and was implanted with unknown synthes 22mm radial head with a standard neck and number 6mm stem.On (b)(6) 2016, the patient complained of some pain in the elbow especially with motion.Radiography showed good alignment of the hardware with the reduced glenohumeral humeral joints.On (b)(6) 2016, the patient stated that her hinged-elbow brace had been loose and needs to be refitted.Radiography showed overall good alignment of the ulnohumeral and radio capitellar joints and hardware in place.On (b)(6) 2016 and (b)(6) 2016, the patient reported night sweats and weight gain of 5lbs.The patient had some limitations of motion overall but stated that the pain was well controlled.Radiography showed good alignment of the radial head and reduced ulnohumeral joint.On (b)(6) 2017, the patient went to the clinic for re-evaluation and noted some increased pain in the anterior aspect and elbow.Radiography showed congruent elbow joint with some lucency noted at the stem of the radial head arthroplasty.On (b)(6) 2017, the patient reported some stiffness and some tingling in the fingers very intermittently.The patient felt mild distal pain with rotation of the supination and pronation.Radiography showed increased lucency at the radial head arthroplasty site.On (b)(6) 2017, the patient reported stiffness and occasional tingling in the right elbow.Patient progressed well with full return to activities and eventually returned to the clinic with increased lateral elbow pain.Right elbow radiograph showed loose radial head arthroplasty with proximal radius osteolysis and reduced elbow joint.A soft tissue anchor was present in the lateral condyle upon fluoroscopy.Surgical anchor was again noted in the lateral epicondyle upon elbow radiographs.Small elbow joint effusion was suspected.

• 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: 8130319
• MDR Text Key: 129301662
• Report Number: 2939274-2018-55265
• Device Sequence Number: 1
• Product Code: KWI
• 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: 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 68