MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIAL HEAD W/ 19MM HD,6.5MM STM,9(+6)MM HD HT,STER; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 09.405.966S

Device Problem Device Slipped (1584)

Patient Problem Unspecified Tissue Injury (4559)

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.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) 2021, the radial head implant in the patient had become unstable due to bone loss radially.There is no further information available.This report is for one (1) radial head w/ ø19mm hd,ø6.5mm stm,9(+6)mm hd ht,ster.This is report 1 of 1 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.H10 additional narrative: the overall complaint condition can be confirmed as the radial head can be seen dislocated from the actual position from the available image.The potential cause of the complaint condition may be due to patient condition and deviating from the technique guide.The guide clearly indicates of the caution that could have caused the subluxation due to certain patient condition.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot part # 09.405.966s.Synthes lot # 6976060.Supplier lot # 6976060.Release to warehouse date: 13 oct 2020.Expiration date: 31 aug 2025.Supplier: viant upland llc.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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: RADIAL HEAD W/ 19MM HD,6.5MM STM,9(+6)MM HD HT,STER
• 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: 11629821
• MDR Text Key: 244277672
• Report Number: 2939274-2021-01729
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982300577
• UDI-Public: 10886982300577
• Combination Product (y/n): N
• PMA/PMN Number: K183618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 09.405.966S
• Device Catalogue Number: 09.405.966S
• Device Lot Number: 6976060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Patient Sequence Number: 1