MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 04.402.008S

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient¿s weight is unknown.Initially implanted earlier this year in 2017.Complainant device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed: part #: 04.402.008s, lot#: 7607062 (sterile) - 8mm ti straight radial stem 28mm-sterile, (b)(4), manufacturing date: 28-jul-2014, expiration date: 30-jun-2019, components: part 21014, lot: 6190711.Raw material lot number 7557656 reviewed.(b)(4).(b)(4) product certification for titanium meets specification.Inspection sheet for incoming final inspection meets specification.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.Sterility documentation was reviewed and determined to be conforming.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, 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 a synthes radial head implant was removed on (b)(6) 2017 after fixation was nearing failure due to osteolysis around the stem as evidenced by lucency visible on the pre-op x-rays.The radial head and stem were removed intact.The patient was not implanted with any new hardware.No surgical delay.The implants were initially implanted earlier this year in 2017.Concomitant devices reported: 22mm cocr radial head standard height/12.5mm-sterile (part # 09.402.022s, lot # 7068118, quantity # 1).This report is for one (1) 8mm ti straight radial stem 28mm-sterile.(b)(4).

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7156765
• MDR Text Key: 96139137
• Report Number: 2939274-2018-50003
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128058
• UDI-Public: (01)10886982128058(17)190630(10)7607062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• 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: 04.402.008S
• Device Catalogue Number: 04.402.008S
• Device Lot Number: 7607062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Date Device Manufactured: 07/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention