MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number	04.402.009S
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: only event year is known: 2018.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 or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a removal of the left elbow due to painful retained hardware involving the radial head replacement from synthes.On (b)(6) 2014, the patient had a left radial head fracture and underwent a replacement of the left radial head utilizing the synthes size 24 standard head and a size 9 mm straight stem.Concomitant devices reported: 24mm cocr radial head standard height/13.0mm-sterile (part number 09.402.024s, lot 7504369, quantity 1).This report involves one (1) 9mm ti straight radial stem 30mm-sterile.This is report 2 of 2 for (b)(4).
Additional 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 or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a removal of the left elbow due to painful retained hardware involving the radial head replacement from synthes.On (b)(6) 2014, the patient had a left radial head fracture and underwent a replacement of the left radial head utilizing the synthes size 24 standard head and a size 9 mm straight stem.On (b)(6) 2018, the patient had an ap lateral oblique views of the left elbow which shows a loose radial head implant.Concomitant devices reported: 24mm cocr radial head standard height/13.0mm-sterile (part number: 09.402.024s, lot: 7504369, quantity 1).This report involves one (1) 9mm ti straight radial stem 30mm-sterile.This is report 2 of 2 for (b)(4).
Additional 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: h3, h6: manufacturing location: supplier - (b)(4) / inspected, packaged and released by: (b)(4).Manufacturing date: april 10, 2013 expiration date: february 28, 2018 part number: 04.402.009s, 9mm ti straight radial stem 30mm ¿ sterile lot number: 7012246 (sterile) lot quantity: 48 work order traveler met all inspection acceptance criteria.Certificate of compliance received from (b)(4) dated february 1, 2013 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label logs lppf, lmd/lpf were 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) lbs.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.March 30, 2020 dhr reviewed 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.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.
Additional 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.

• Brand Name: 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE
• Common Device Name: 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: 9962335
• Report Number: 2939274-2020-01839
• Device Sequence Number: 2826629
• Product Code: KWI
• UDI-Device Identifier: 10886982128065
• UDI-Public: (01)10886982128065
• Combination Product (Y/N): N
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 04.402.009S
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7012246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020; 04/30/2020; 05/06/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 04/15/2020; 05/06/2020; 05/07/2020
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1124-2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 24MM COCR RADIAL HEAD STANDARD HEIGHT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Weight: 82