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
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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.
Additional 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.
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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: 7134212
• Report Number: 2939274-2017-50382
• Device Sequence Number: 1290316
• Product Code: KWI
• UDI-Device Identifier: 10886982128058
• UDI-Public: (01)10886982128058(17)210331(10)H091254
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 01/03/2018; 01/03/2018; 03/14/2018; 03/26/2018; 04/02/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/19/2018; 03/13/2018; 03/16/2018; 04/19/2018; 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1124-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 105