MAUDE Adverse Event Report: SYNTHES USA 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Catalog Number 04.402.007S

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient weight is not available for reporting.Event date: unknown.This report is for one (1) unknown radial stem.Part and lot number is unknown.Without a valid part and lot number, the udi is not available.Device is not expected to be returned for manufacturer review/investigation.The (510k): unknown.(b)(4).Without a lot number the device history records review could not be completed.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 surgery on (b)(6) 2016 for the implantation of a radial head prosthesis system.It was reported that during a six week checkup, the patient was complaining of having very limited motion and is not happy with the outcome.The devices remain intact and a bone scan is planned to determine if there is any loosening of the devices.The patient had the bone scan completed on an unknown date and that it showed the loosened radial stem.It was also reported that the surgeon stated that the stem was pistoning (moving up and down) in the patient's arm and that was what was causing her pain.The patient underwent hardware removal on (b)(6) 2017 for confirmed loosening of the radial stem.There were no issues reported with the radial head.It is reported that the surgeon felt the patient's arm was stable and therefore, did not replace the hardware.The surgery was successfully completed without any issues or delay and the patient was reported as stable.Concomitant device: unknown radial head (part #unknown, lot #unknown, quantity 1).This report is for one (1) unknown radial stem.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Without a lot number the device history records review could not be completed.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 the patient was implanted with a radial head prosthesis system to her right elbow on or around september 19, 2016 (per initial information found in (b)(4), the implant date was (b)(6), 2016).It was further reported that since the implantation of the devices in september 2016, the patient continues to suffer from permanent physical injuries including pain and swelling of her right elbow, especially directly over the proximal radial area.As initially reported, the devices were explanted on (b)(6), 2017.

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.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.A review of the device history records has been requested.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 underwent removal of right radial head prosthesis system on (b)(6) 2017.Patient underwent open reduction and internal fixation on (b)(6) 2016 and was implanted with radial head prosthesis system due to broken right elbow that happened in an adult relay type race in which patient was on a set of monkey bars and fell to the ground.On (b)(6) 2016 pre-operative computed tomography (ct) scan taken and revealed severely comminuted, intra-articular fracture head and neck with a large joint effusion.Initial surgery was successful, patient was in stable condition with no complications.On (b)(6) 2017 bone scan revealed lucency around the stem of the radial head prosthesis.On (b)(6) 2017, during the follow up visit, patient had not progress in motion and having a lot of pain.On an unknown date, patient had a postoperative x-rays that showed osteolysis around the stem of the radial head prosthesis and the radial head prosthesis was poisoning in the bone based on the x-rays.During revision procedure, the tissue around the joint was noted to very hypertrophic.The radial head implant was noted to be very loose and was spinning freely around the bone and has also positioned out more proximally up against the capitellum.The radial head was disarticulated from the stem.The head was removed and the stem was removed and came out without any difficulty.There was absolutely no bonding to the bone with it.The removal surgery was successfully completed without any issues or delay and the patient was reported as stable.

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part# 04.402.007s, lot# 7838215.Manufacturing location: (b)(4), manufacturing date: mar 31, 2015, expiry date: feb 28, 2020.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from alalign dated (b)(6) 2015 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part reviewed: part: 21014, lot: 7557656, certified test report supplied by perryman company dated (b)(6) 2013 and inspection certificate supplied by vsmpo dated (b)(6) 2012 were reviewed and determined to be conforming.Lot summary report dated (b)(6) 2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.The x-rays were reviewed and based on the x-rays alone, this complaint could not be confirmed.However, there are known issues with the radial head implants and relevant actions have been initiated to address them.Based on these information the complaint for loosening can be confirmed.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The complaint condition is confirmed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed based on the image that may have contributed to the 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.

• Brand Name: 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 6432807
• MDR Text Key: 70858751
• Report Number: 2520274-2017-11055
• 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
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 7838215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: RADIAL HEAD (PART #UNKNOWN, LOT # UNKNOWN, QTY 1); RADIAL HEAD (PART #UNKNOWN, LOT #UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 73