MAUDE Adverse Event Report: SYNTHES MONUMENT 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.024S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Event date unknown.One (1) unknown radial head prosthesis /unknown lot.Part and lot number are unknown; udi number is unknown.Explant date 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.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 after sustaining an injury, a patient was implanted with a radial head prosthesis on (b)(6) 2016.Following the surgery, the patient underwent physical therapy, but continued to experience problems with the elbow, including limited range of motion, pain, and weakness.She was eventually released to play tennis by her surgeon in (b)(6) 2016.While hitting a ball on (b)(6) 2017, the patient sustained a radial head periprosthetic fracture that required another surgery.This report is for 1 unknown radial head prosthesis.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Udi # (b)(4).The device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review part number: 09.402.024s, synthes lot number: h034551, supplier lot number: na, release to warehouse date: 02-feb-2016, manufactured by: monument.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this products, and any subcomponents, which would contribute to this complaint condition.(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.

Manufacturer Narrative

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

Updated udi: (b)(4).Expire date: jan 31, 2021.Updated device history records review.The report indicates that: lot #h034551.Dhr review: part number: 09.402.024s, synthes lot number: h034551 , supplier lot number: na , release to warehouse date: 24-feb-2016, expiration date: 31-jan-2021, manufactured by: monument.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this products, and any subcomponents, 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.

Manufacturer Narrative

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

Update: it was reported that the patient had a radial head excision due to pain and prosthetic joint loosening on (b)(6) 2017.The surgery was successfully completed with no additional medical intervention or delay noted.

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.Complaint was assessed and is being reported as an adverse event and product problem.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

Update: it was reported that during the open reduction internal fixation (orif)/ostetomy/head resection done on (b)(6) 2018, the radial head prosthetic was removed easily once the radial head joint was opened up.After the blunt dissection and all the fracture fragments being excised, there was a smotth motion of the elbow with full supination and pronation, flexion and extension without any instability laterally.Concomitant device reported: unknown radial stem.

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.Additional narrative: event: updated event description.Other relevant history: updated medical history.Udi#: updated udi to new format.Common device name: updated concomitant device.Corrected data: event: concomitant device reported: unknown radial stem.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: 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6959692
• MDR Text Key: 89714775
• Report Number: 1719045-2017-11080
• Device Sequence Number: 1
• Product Code: KWI
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.402.024S
• Device Lot Number: H034551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 59