MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number 09.402.018S

Device Problem Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)

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) 2018, the patient underwent a removal of implant (deep) due to loosening and periprosthetic fracture, and anconeus rational myoplasty.A brachial plexus on-q catheter was also placed.An incision was made over the anconeous.The fascia was incised over the anconeous, pedicled it off the neurovascular pedicle and took it off the ulna.The capsuled was also incised.The implant basically fell out of the wound and multiple culture of the scar tissue were taken.The capitellum was eburnated.Fluoroscopy was performed both in varus-valgus and at the druj was stable.The top of anconeous was pedicle into the joint and then the capsule was closed using 2 mitek g2 anchors.The elbow was stable at this point.On (b)(6) 2015, the patient who was mountain climbing in an indoor gym when she noted immediate pain and discomfort in the right elbow after a fall from about 15 feet.The pain was severe, and the patient felt that her elbow was out of position.On (b)(6) 2015, radiographs showed a comminuted fracture of the radial head with impaction with subluxed radial head.A closed reduction of the right elbow was performed.On (b)(6) 2015, the patient underwent a right radial head replacement and right lateral ulnar collateral ligament repair due to right comminuted radial head fracture and right radial head dislocation and was implanted with a synthes radial head prosthesis.On (b)(6) 2016, the patient went to the clinic and complained of increased pain after initiation of strengthening of the right upper extremity.The patient reported that she began to have some pain which was worse with forced pronation with associated weakness and pain in the hands and intrinsic hand muscles., which appeared to be a type of fatigue in limitation which limits her from doing some of the activities what she enjoys.On (b)(6) 2016, the patient had a clinic visit and complained of minimal pain at end range of motion (rom).Radiograph demonstrated that the implant was in place but had moderate degree of osteolysis around the stem.On (b)(6) 2017, the patient went to a clinic and complained of some mild limited motion.Radiography showed a radial head replacement with proximal radius osteolysis.On (b)(6) 2017, the patient had an injury while trying to do an indoor rock climb and sustained a right elbow injury resulting in a small periprosthetic crack in the osteolytic radial head.On (b)(6) 2017, during clinic visit, the patient stated that she was trying to push up from her right upper extremity when she noted immediate pain and discomfort in the right elbow.The pain was severe and associated with some discomfort with pronation and supination of the forearm.There was continued osteolysis based on the result of the radiograph taken.On (b)(6) 2017, the patient had a small amount of lateral epicondylitis which was irritating on the lateral aspect of the elbow.Radiograph showed a slight subsidence of the radial head.On (b)(6) 2018, the patient was seen for initial evaluation for right l4/l5 facet dysfunction.The patient reported of right hip pain from hiking that started over a year ago and yoga positions, like downward dog, aggravates her hip.On (b)(6) 2018, the patient came to the clinic and complained of right elbow pain after lifting herself up using her arms.The pain was severe and sharp and localized to the right elbow.The patient was unable to comfortably pronate and supinate the right upper extremity and stated that she injured her elbow on (b)(6) 2018.Radiography showed a displaced proximal radius periprosthetic fracture at the level of the radial head prosthesis.On (b)(6) 2018, the patient visited the clinic and complained of pain and limited motion after she felt a crack while pushing up on her arm.X-ray showed a fracture through the proximal radius with a loose radial head replacement.From (b)(6) 2018 to (b)(6) 2018, the patient reported upon follow-up clinic visit that the on-q nerve block pump leaked at the pump-to-catheter adapter which resulted to the return of sensation to the right arm a day after the surgery.The patient experienced an allergic reaction to medications which resulted in facial swelling and hives all over the body and taking oxycodone-acetaminophen resulted in exacerbated symptoms and intensely painful burning sensation at the surgical site.The patient also reported feeling aching, burning, sharp, throbbing, cramping, dull and prickly pain with associated swelling, fatigue, tenderness, tingling, weakness and stiffness, and radiating symptoms.There was also difficulty sleeping at night due to pain.Concomitant device reported: competitor¿s device: unknown g2 anchors (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 18mm cocr radial head standard height/11.5mm-sterile.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.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 at customer quality on the device images provided showed no issues of stem loosening.Per all the mris reviewed, the complaint was not able to be confirmed.However, there are known issues with the radial head implants that are captured in capa-006651.There is also a recall (recall# 555531) that was initiated as part of field action investigation.A device history review, was performed for the returned instrument¿s lot number, and no ncrs, no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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 images) that may have contributed to the complaint condition.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# 555531 investigations.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 were received on 07may2019 and were received.From the review no new conclusions can be drawn.Device history lot manufacturing location: supplier - nemcomed / inspected, packaged and released by: monument release to warehouse date: 25-jul-2012, expiration date: 30-jun-2017, part number: 09.402.018s, 18mm cocr radial head standard height/11.5mm ¿ sterile, lot number: 6905701 (sterile).This lot met all dimensional, visual 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.Component part(s) reviewed: part number: 21022, tialnbri8.00, lot number: 5317556, part number: 41044, cocrmori50.80, lot number: 6046922.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.

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 history records review was completed for part: 09.402.018s, lot: 6905701.Manufacturing location: monument, manufacturing date: jul 25, 2012, expiry date: jun 30, 2017.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.Visual inspection performed at customer quality on the device images provided showed no issues of stem loosening.Per all the mris reviewed, the complaint was not able to be confirmed.Relevant actions have been taken/initiated to address this issue.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 images) that may have contributed to the complaint condition.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.See related 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary updated on 01aug2019 due to new images received.New images were received.From the review no new conclusions can be drawn.Per all the mris (24 images from the 24 attachments located in notes & attachments section of the product complaint) reviewed, the complaint was not able to be confirmed by us cq.However, there are known issues with the radial head implants that are captured in capa-006651.There is also a recall (recall# 555531) that was initiated as part of field action investigation hhe-2016-180.A device history review, was performed for the returned instrument¿s lot number, and no ncrs, no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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 images) that may have contributed to the complaint condition.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# 555531 and hhe-2016-180 investigations.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.See related 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.

• Brand Name: 18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-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: 8422076
• MDR Text Key: 138897261
• Report Number: 2939274-2019-56968
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132574
• UDI-Public: (01)10886982132574
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 09.402.018S
• Device Catalogue Number: 09.402.018S
• Device Lot Number: 6905701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR