MAUDE Adverse Event Report: SYNTHES USA PRODUCTS LLC 20MM COCR RADIAL HEAD 4MM HT EXTENSION/16.0MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Catalog Number 09.402.420S

Device Problems Nonstandard Device (1420); Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Complainant part is not expected to be returned for manufacturer review/investigation, as part remains in the patient and part was discarded by the facility.Patient code (b)(4) used for: devices that are found to have an undesired movement such as shifting, toggling, or do not have a tight fit.Includes implants which toggle due to poor bone purchase/bone ingrowth.

Event Description

This report is against user facility medwatch number mw5073779, a copy is attached.The only information contained in this report is correction or additional information.It was reported that the patient sustained a right olecranon and radial head fracture requiring internal fixation and radial head arthroplasty with radial head implanted on (b)(6) 2016.Orthopedic follow-up imaging demonstrated right elbow loosening of the radial head prosthesis.Olecranon healed without sign of hardware complication.Physical exam noted loosening and symptomatic olecranon hardware with fracture unacceptably displaced.On (b)(6) 2017, the patient underwent right radial head implant removal and olecranon hardware removal.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

(b)(4).Dhr review was completed.Manufacturing location: (b)(4).Packaged by: (b)(4).Manufacturing date: 20-may-2015 expiration date: 30-apr-2020 part #: 04.402.007s, lot#: 7917001 (sterile) - 7mm ti straight radial stem 26mm - sterile.Quantity 25.Components part 21014 bp80 lot: 7557656.Raw material for (b)(4) received from (b)(4).Certified test report for (b)(4), inspection certificate meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for incoming final inspection, certificate of compliance received from (b)(4) and raw material lot: 7557656 were reviewed.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.¿sterility documentation was reviewed and determined to be conforming.¿ manufacturing location: (b)(4).Packaged by: (b)(4).Manufacturing date: 18-may-2013 expiration date: 31-mar-2018 part #: 09.402.420s, lot#: 7181898 (sterile) - 20mm cocr radial head 4mm ht extension/16.0mm - sterile.Quantity 98.Component parts reviewed: part 21022 lot 5317556, material testing for (b)(4) for implant material, product certification received from (b)(4) meet specification.Raw material (ti) inspection sheet meet specification.Raw material receiving/putaway checklist meet requirements.Part 41060 lot 6961191, raw material received from (b)(4).Certificate of tests received from (b)(4) meet specification.Raw material receiving/putaway checklist meet requirements.(b)(4) certificate of compliance meet specification.Inspection sheet for incoming final inspection met inspection acceptance criteria.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.¿sterility documentation was reviewed and determined to be conforming.¿ (b)(4).(b)(6).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 the patient sustained a right olecranon and radial head fracture requiring internal fixation and radial head arthroplasty with radial head implanted on (b)(6) 2016.Orthopedic follow-up imaging demonstrated right elbow loosening of the radial head prosthesis.Olecranon healed without sign of hardware complication.Physical exam noted loosening and symptomatic olecranon hardware with fracture unacceptably displaced.On (b)(6) 2017, the patient underwent right radial head implant removal and olecranon hardware removal and the radial head was replaced.The removal procedure was completed successfully with surgical delay.The patient status was reported to fine post-surgery.

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

Dhr review was completed.Manufacturing location: (b)(4).Packaged by: (b)(4).Manufacturing date: 18-may-2013 expiration date: 31-mar-2018 part #: 09.402.420s, lot#: 7181898 (sterile) - 20mm cocr radial head 4mm ht extension/16.0mm - sterile.Quantity 98.Component parts reviewed: part 21022 lot 5317556, material testing for titanium for implant material, product certification received from dynamet meet specification.Raw material (ti) inspection sheet meet specification.Raw material receiving/putaway checklist meet requirements.Part 41060 lot 6961191, raw material received from carpenter technology.Certificate of tests received from carpenter meet specification.Raw material receiving/putaway checklist meet requirements.(b)(4) of compliance meet specification.Inspection sheet for incoming final inspection (b)(4)rev: a met inspection acceptance criteria.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.¿sterility documentation was reviewed and determined to be conforming.¿ 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.Device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 20MM COCR RADIAL HEAD 4MM HT EXTENSION/16.0MM-STER
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
• Manufacturer (Section D): SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester 19380
• MDR Report Key: 7208377
• MDR Text Key: 97854376
• Report Number: 2939274-2018-50347
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 09.402.420S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 69