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

Model Number 04.402.010S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.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) 2019, the patient underwent a revision of left radial head replacement due to left radial head replacement with complication.On an unknown date, the patient fell off a loading dock resulting in a right lateral condyle distal femoral fracture and left radial head fracture.On (b)(6) 2016, the patient underwent a left radial head replacement/arthroplasty, due to the left comminuted radial head fracture and right orif of distal femur lateral condyle fracture, due to right lateral condyle distal femoral fracture.On (b)(6) 2019, the patient presented a left elbow pain.The x-rays showed the left elbow lucency around the stem of the radial head implant and no joint space between hardware articulation.On (b)(6) 2019 the patient is still having pain and weakness in the elbow and over time it has progressively worsened.The patient reports to the clinic about four weeks out from a post-revision left radial head replacement.Concomitant devices reported: 24mm cocr radial head standard height/13.0mm-sterile (part number 09.402.024s, lot 7683419, quantity 1).This report involves one (1) 10mm ti straight radial stem 32mm-sterile.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.Manufacturing location: supplier - (b)(4) / inspected, packaged and released by: monument.Release to warehouse date: march 8, 2013.Expiration date: january 31, 2018.Part number: 04.402.010s, 10mm ti straight radial stem 32mm ¿ sterile.Lot number: 7012270 (sterile).Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Certificate of compliance received from (b)(4) dated december 28, 2012 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified this lot met all dimensional, visual, sterility 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: 21014, tialnbri16.00.Lot number: 6768793.Lot quantity: (b)(4).Product traveler met all inspection acceptance criteria.Product certification supplied by dynamet dated august 22, 2011 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.April 8, 2020 dhr reviewed.This lot met all dimensional, visual, sterility and packaging with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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

Update: received additional medical records regarding (b)(6) ((b)(4)).

Manufacturer Narrative

Product complaint # (b)(4).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: b5: additional information, medical records were provided and have been attached to the complaint record.H, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

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.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.H3, h4, h6- the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could not be confirmed as no device related issues could be observed.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument, release to warehouse date: 08-mar-2013, expiration date: 31-jan-2018, part number: 04.402.010s, 10mm ti straight radial stem 32mm ¿ sterile, lot number: 7012270 (sterile), component part(s) reviewed: part number: 21014, tialnbri16.00, lot number: 6768793, this lot met all dimensional, visual, sterility and packaging 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: 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: 9964400
• MDR Text Key: 194773232
• Report Number: 2939274-2020-01852
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128072
• UDI-Public: (01)10886982128072
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 04.402.010S
• Device Catalogue Number: 04.402.010S
• Device Lot Number: 7012270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: 24MM COCR RADIAL HEAD STAND HEIGHT/13.0MM
• Patient Outcome(s): Required Intervention