MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.010S

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial stem / unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review / investigation.Reporter is attorney.(b)(4).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.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 a removal of the radial head prosthesis left elbow due to loosening.Reportedly, on (b)(6) 2017, the patient underwent an open reduction and internal fixation of the comminuted left proximal ulna and where a synthes device was implanted.Prior to the reported event, the patient tripped over a curb and fell her on her left upper extremity resulting to an immediate severe pain.On an unknown date, the patient had a third surgery to replace a broken hardware and plate with a nonunion and had illac crest bone grafting and was implanted with unknown devices.On (b)(6) 2019, the patient underwent another procedure to remove the hardware and had an ulnar nerve release.It was unknown if a synthes device was involved.On (b)(6) 2019, the patient had an increased pain and x-ray revealed a re-break of her ulna.On (b)(6) 2019, past six weeks, patient still had an increased pain and noticed a deformity and limited motion on her arm.There was a limited movement on her fingers, numbness and tingling in the ring and small finger.This report captures the removal of the radial head prosthesis left elbow due to loosening on (b)(6) 2017.This report is for one (1) unknown radial stem.This is report 2 of 2 for complaint (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.Corrected data: pma/510k awareness date reported on follow up 1 report as october 15, 2019 but should have been november 19, 2019.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.The complaint condition could not be confirmed according to the received pictures.The reported products could not be seen on the received photos.Furthermore, the dhr review could not be performed due the missing part and lot number.Product was not returned.Based on the information available, it has been determined that no corrective and 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

(b)(6) 2019, the patient underwent a hardware removal due to pain, nerve injury and non-union.The two (2) 2.0mm screws, four(4) locking screws, two (2) compression screws, one (1) 4 hole 2mm plate and one (1) olecranon plate were removed.It is unknown if there was a surgical delay.Patient outcome is unknown.On (b)(6) 2019 an x-ray was taken due to an increase in pain.This showed a re-break of her ulna.On (b)(6) 2019, the patient underwent an open treatment and internal fixation of left ulnar shaft nonunion w/ distal radius bone graft and reduction of radius dislocation at elbow due to left ulnar shaft nonunion and radial head dislocation.

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.H10 additional narrative: a1: updated patient's initial.B5: additional information.B6: updated tests/lab data, including dates information.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

On (b)(6) 2019, the patient is c/o left arm and finger paresthesia involving mostly digits 1-3 but occasionally digits 4-5 also.She has wrist pain and has a prior nerve release.On (b)(6) 2019, the patient is still in a lot of pain.She states that her pain at rest is 8/10.It is better with the splint on but she still has pain.It wakes her from sleep.Motion and use make it worse.Her wrist pain is 9/10; it is mostly ulnar but can be dorsal and radial as well.She is getting numbness and tingling in the thumb, index, and middle finger and numbness at the base of the thumb.Rotation makes her pain worse.It is sharp.She had an issue supinating for the mri and had more significant pain.On (b)(6) 2019, the patient reports that she has been in increased pain.She has had lots of pain lately.It is worse since the last visit.She said that she has posterior lateral elbow pain.She notices a bump there.She noticed it before, but now the pain is constant.She has numbness on the dorsal side of the scar.She reported that she had a deep pain in the antecubital fossa area; this is constant and goes deep in the elbow.She has a lump in the anterior third of the forearm which she has not noticed before.She even noticed burning in the elbow, and she gets numbness and tingling in the thumb and index finger which is constant and over the palm and dorsal wrist.On (b)(6) 2020, the patient reports her continued problems; really no significant change from previous.Her pain is 8/10 in the antecubital fossa.She reports it is a deep, dull throb.Her wrist has 9/10 pain on the ulnar side, and her ulnar shaft is about 8/10 pain.She states she still gets numbness and tingling in the thumb, index, and middle finger which is intermittent; it can be random.On (b)(6) 2020, the patient got soreness in the arm.There is soreness in the elbow.There is a throbbing discomfort.The antecubital fossa is sore.She has wrist pain.She has pain with twisting in the dorsal and ulnar aspects of the wrist.She gets numbness and tingling in the thumb and index finger.She is six months post-surgery.She did a ct scan.

Event Description

Updated event description: it was reported that on (b)(6) 2017, the patient underwent a removal of the radial head prosthesis left elbow.Reportedly, on (b)(6) 2017, the patient underwent an open reduction and internal fixation of the comminuted left proximal ulna and where a synthes device was implanted.Prior to the reported event, the patient tripped over a curb and fell her on her left upper extremity resulting to an immediate severe pain.On an unknown date, the patient had a third surgery to replace a broken hardware and plate with a nonunion and had illac crest bone grafting and was implanted with unknown devices.On (b)(6) 2019, the patient underwent another procedure to remove the hardware and had an ulnar nerve release.It was unknown if a synthes device was involved.On (b)(6) 2019, the patient had an increased pain and x-ray revealed a re-break of her ulna.On (b)(6) 2019, past six weeks, patient still had an increased pain and noticed a deformity and limited motion on her arm.There was a limited movement on her fingers, numbness and tingling in the ring and small finger.On (b)(6) 2019, the patient underwent a bone graft radius/ulna and repair.On (b)(6) 2019, the patient is c/o left arm and finger paresthesia involving mostly digits 1-3 but occasionally digits 4-5 also.She has wrist pain and has a prior nerve release.On (b)(6) 2019, the patient is still in a lot of pain.She states that her pain at rest is 8/10.It is better with the splint on but she still has pain.It wakes her from sleep.Motion and use make it worse.Her wrist pain is 9/10; it is mostly ulnar but can be dorsal and radial as well.She is getting numbness and tingling in the thumb, index, and middle finger and numbness at the base of the thumb.Rotation makes her pain worse.It is sharp.She had an issue supinating for the mri and had more significant pain.On (b)(6) 2019, the patient reports that she has been in increased pain.She has had lots of pain lately.It is worse since the last visit.She said that she has posterior lateral elbow pain.She notices a bump there.She noticed it before, but now the pain is constant.She has numbness on the dorsal side of the scar.She reported that she had a deep pain in the antecubital fossa area; this is constant and goes deep in the elbow.She has a lump in the anterior third of the forearm which she has not noticed before.She even noticed burning in the elbow, and she gets numbness and tingling in the thumb and index finger which is constant and over the palm and dorsal wrist.On (b)(6) 2020, the patient reports her continued problems; really no significant change from previous.Her pain is 8/10 in the antecubital fossa.She reports it is a deep, dull throb.Her wrist has 9/10 pain on the ulnar side, and her ulnar shaft is about 8/10 pain.She states she still gets numbness and tingling in the thumb, index, and middle finger which is intermittent; it can be random.On (b)(6) 2020, the patient got soreness in the arm.There is soreness in the elbow.There is a throbbing discomfort.The antecubital fossa is sore.She has wrist pain.She has pain with twisting in the dorsal and ulnar aspects of the wrist.She gets numbness and tingling in the thumb and index finger.She is six months post-surgery.She did a ct scan.On (b)(6) 2020, the patient presents severe pain to the left elbow and forearm.The patient states that she began noticing the pain in the middle of the night sunday night while she was sleeping.She states that the pain has continued to worsen ever since then.She states that she always has her splint on except for sleeping.She denies any event or injury or activity that she can recall coinciding with the severity of her symptoms.On (b)(6) 2020, the patient reports she has been casted for about a week and a half to two weeks; it felt heavy.She is noticing pain and swelling.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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.H10 additional narrative: b5, b6, b7: additional information.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

Additional event information: it was reported that on (b)(6) 2020, the patient underwent removal of left proximal ulnar hardware and left ulnar nonunion repair with left iliac crest bone grafting and cerement.On (b)(6) 2020, the patient came for a follow-up of her left shoulder.She has had continued issues with the left elbow, as well as some additional surgeries.She is starting to develop a little bit of pain in the front portion of the left shoulder, which could be related to some of her elbow issues, as she still has some limitations with elbow function.She is currently in a bone stimulator for her left elbow.She does not have any specific injury or trauma to the shoulder itself, just some increasing symptoms on the front portion of the shoulder, as well as occasionally on the back.This report is for one (1) 10mm ti straight radial stem 32mm-sterile.

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.H6: manufacturing location: supplier - (b)(4), packaged and released by: monument, release to warehouse date: august 21, 2014, expiration date: july 01, 2019, part: 04.402.010s, 10mm ti straight radial stem 32mm ¿ sterile, lot: 7608055 (sterile).Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 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 inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part: 21014, tialnbri16.00 lot: 6190711.Product traveler met all inspection acceptance criteria.Product certification supplied by dynamet was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.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: 10MM TI STRAIGHT RADIAL STEM 32MM-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: 9288195
• MDR Text Key: 165576541
• Report Number: 2939274-2019-62003
• 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: consumer,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 04.402.010S
• Device Lot Number: 7608055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2020
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 102