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 Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4), packaged by: (b)(4).Manufacturing date: 03-may-2016.Expiration date: 31-mar-2021.Part #: 04.402.008s, lot#: h091254 (sterile) - 8mm ti straight radial stem 28mm-sterile, quantity 22.Inspection sheet for incoming final inspection meets specification.Raw material part 21014 lot number 7557656 reviewed.Raw material for titanium provided by (b)(4).Certified test report received from (b)(4) meet specification.Raw material receiving/putaway checklist meet specification.Certificate of compliance for titanium received from (b)(4) met specification.Packaging component reviewed and they 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.¿sterility documentation was reviewed and determined to be conforming.¿ h3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent a removal of radial head prosthesis on (b)(6) 2017 due to pain, bone damage and loosening of the radial stem.The patient was initially implanted with radial head prosthesis on (b)(6) 2016 for an unknown reason.Subsequently, the patient and their surgeon became aware of the radial head loosening in (b)(6) 2017, however, surgeon decided to wait and let the bone heal as described by the patient.Radiographic images taken (unavailable) during a follow-up visit before the removal of radial head prosthesis were described by the patient to show air around the x-ray.During a follow-up visit in (b)(6) 2017, the surgeon decided to remove the radial head and the removal procedure was conducted on (b)(6) 2017.Concomitant devices reported: radial head (part 09.402.024s, lot h086270, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Patient height reported as 5 feet 8 inches; additional medical history.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

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

Patient fell outside a local store injuring her elbow on (b)(6) 2016 and went to emergency room on (b)(6) 2016.She was then sent to orthopedic office after x-rays taken showed radial head fracture.Surgical treatment was on (b)(6) 2016 with a radial head initial implant.Removal of radial head prosthesis occurred (b)(6) 2017; multiple cultures were taken.Synthes screwdriver was used to screw off the radial head and this was removed.Next, a kocher was used to take out the prosthesis itself.Rongeurs were used to rongeur around any at the end of the radial neck, these were then sent for culture, and copious irrigation was placed inside the wound.Routine bacterial culture and anaerobic cultures were taken from left radial neck and left elbow joint.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Alert date for report mwr-(b)(4); report follow up 2, is (b)(6) 2018.Correction was noted on (b)(6) 2018.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 03-may-2016.Expiration date: 31-mar-2021.Part #: 04.402.008s, lot#: h091254 (sterile) - 8mm ti straight radial stem 28mm-sterile, quantity 22.Inspection sheet for incoming final inspection meets specification.Raw material part 21014 lot number 7557656 reviewed.Raw material for titanium provided by (b)(4).Certified test report received from (b)(4) meet specification.Raw material receiving/putaway checklist meet specification.Certificate of compliance for titanium received from (b)(4) met specification.Packaging component reviewed and they 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.¿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.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: 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: 7134212
• MDR Text Key: 95377210
• Report Number: 2939274-2017-50382
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128058
• UDI-Public: (01)10886982128058(17)210331(10)H091254
• 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: other
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 04.402.008S
• Device Catalogue Number: 04.402.008S
• Device Lot Number: H091254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• Date Device Manufactured: 05/03/2016
• 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
• Patient Age: 61 YR
• Patient Weight: 105