MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 04.402.027S

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4), packaged by: (b)(4) manufacturing date: 28-aug-2014, expiration date: 30-jun-2019.Part #: 04.402.027s, lot#: 7607072 (sterile) - 7 mm ti curved radial stem 42mm-sterile.Quantity 131.Raw material part no: (b)(4) lot number- 5490857 reviewed.Certificate of test for (b)(4) raw material received from allvac and raw material inspection sheet meet specification.Raw material receiving/putaway checklist meet specification.Inspection sheet for incoming final inspection meet inspection criteria.Certificate of compliance from avalign ((b)(4)) for (b)(4) meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Scn no: sterigenics (corona).¿sterility documentation was reviewed and determined to be conforming.¿ 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 a hardware removal procedure took place on (b)(6) 2018 due to the loosening of a radial head prosthesis stem implant.The patient came to the emergency room on an unknown date with unknown complaints.It was during that visit that an x-ray was taken and it was discovered that the radial head prosthesis stem was loose.Both parts of the two-piece implant were removed during the (b)(6) procedure.The x-ray taken in the emergency room is not available.The hardware removal procedure was reported to have been completed successfully with no complications.The patient was not revised to anything because her fracture was stable.The patient was reported to be in good condition following the procedure.No information is available about the original implant procedure of the device.This report involves 1 devices.Reported concomitant device 22mm cocr radial head (part number: 09.402.622s, lot number: 7607102, quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient height reported as 170.0 cm.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 a hardware removal procedure took place on (b)(6) 2018 due to the loosening of a radial head prosthesis stem implant.The patient came to the emergency room on an unknown date with unknown complaints.It was during that visit that an x-ray was taken and it was discovered that the radial head prosthesis stem was loose.Both parts of the two-piece implant were removed during the (b)(6) procedure.The x-ray taken in the emergency room is not available.The hardware removal procedure was reported to have been completed successfully with no complications.The patient was not revised to anything because her fracture was stable.The patient was reported to be in good condition following the procedure.No information is available about the original implant procedure of the device.This report is for one (1) 7mm curved radial stem 42mm.This is report 1 of 1 for (b)(4).

Event Description

This report is 1 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.Date of implant is unknown.Product development investigation was completed.The returned ti curved radial stem (04.402.027s, 7607072) is part of the radial head prosthesis system intended for primary and revision joint replacement of the radial head.The returned stem was received with a stem screw from the returned radial head implant embedded in it, which did not confirm the complaint condition of loosening, but the broken stem screw being jammed in the returned head was confirmed.Relevant drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No material review reports, non-conformance reports, or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record showed that there were no issues during the manufacture of the product, which would contribute to the complaint condition.The material properties of the returned part were determined to be conforming at the time of manufacture and based on review of the associated/available device history records and based on the details of the complaint and investigation of the returned part, additional material testing is not required.During the investigation, no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Relevant actions have been taken to address the matter.Due to the broken radial head screw being broken and embedded in the returned stem, and the remaining screw portion unable to be removed from its location in the head, dimensional checks of relevant dimensions could not be performed.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: 7MM TI CURVED RADIAL STEM 42MM-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: 7384221
• MDR Text Key: 103915867
• Report Number: 2939274-2018-51337
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096(17)190630(10)7607072
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7607072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 59