MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RAD STEM UNCEM STRAIG SIZ 6 L24 TAN; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.006S

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial head prosthesis: radial stem/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 depuy synthes radial head loosened and failed requiring a radial head implant excision, radial head arthroplasty and ligament reconstruction, together with other ongoing medical care.On or about (b)(6) 2016, the patient underwent an open reduction internal fixation procedure for her left elbow which included the implantation of a depuy synthes radial head prosthesis system.On (b)(6) 2017, the patient was advised by her surgeon that the depuy synthes radial head prosthesis system had been the subject of a recall which completely removed the product from the market.This report involves 1 unknown radial head prosthesis:radial stem.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 d11 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 depuy synthese radial head loosened and failed requiring a radial head implant excision, radial head arthroplasty and ligament reconstruction, together with other ongoing medical care.On or about (b)(6) 2016, the patient underwent an open reduction internal fixation procedure for her left elbow which included the implantation of a depuy synthese radial head prosthesis system.On an unknown date, the radial head loosened and failed requiring a (b)(6) 2017 radial head implant excision, radial head arthroplasty and ligament reconstruction, together with other ongoing medical care.On (b)(6) 2017, the patient was advised by her surgeon that the depuy synthese radial head prosthesis system had been the subject of a recall which completely removed the product from the market.Concomitant devices reported: radial head prosthesis (part number unknown, lot unknown, quantity 1).This report involves one (1) unknown radial head prosthesis: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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s) received by (b)(6) 2021.No evidence of the radial head or stem loosening was identified in the images.There are known issues with the radial head implants (stems being loosened) 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 where ¿device loosening¿ was identified as a high harm and contributed to the recall of the product.Based on the records, capa, hhe and field action information us cq can confirm the complaint for stem loosening but no issues were identified with the radial heads.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.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 history lot: manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument.Manufacturing date: 26-sep-2014.Expiration date: 31-aug-2019.Part number: 04.402.006s, 6mm ti straight radial stem 24mm ¿ sterile.Lot number: 7601448 (sterile).Component part(s) reviewed: part number: 21014, tialnbri16.00.Lot number: 6190711.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5.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) 2017, patient was revised due to left elbow failed reconstruction, and persistent elbow instability, operative reported also of loose radial stem, pain and instability.

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.The complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s) received by (b)(6) 2021.No evidence of the radial head or stem loosening was identified in the images.There are known issues with the radial head implants (stems being loosened) that are captured in capa.There is also a recall that was initiated as part of field action investigation hhe where ¿device loosening¿ was identified as a high harm and contributed to the recall of the product.Based on the records, capa, hhe and field action information us cq can confirm the complaint for stem loosening but no issues were identified with the radial heads.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.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.Any related investigations and assessment of the risks associated with this system will be covered under recalland hhe 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 history lot : manufacturing location: supplier - (b)(4) / inspected, packaged and released by: (b)(4).Manufacturing date: 26-sep-2014.Expiration date: 31-aug-2019.Part number: 04.402.006s, 6mm ti straight radial stem 24mm ¿ sterile.Lot number: 7601448 (sterile).Component part(s) reviewed: part number: 21014, tialnbri16.00.Lot number: 6190711.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture 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.

Event Description

On (b)(6), 2017, the patient was revised due to left elbow reconstruction failure, and persistent elbow instability, it was reported that there was a loose radial stem, pain, and instability.

• Brand Name: RAD STEM UNCEM STRAIG SIZ 6 L24 TAN
• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10025253
• MDR Text Key: 189901637
• Report Number: 2939274-2020-02242
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 04.402.006S
• Device Lot Number: 7601448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: UNK - RADIAL HEAD PROSTHESIS.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female