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 Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Arthritis (1723); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 5 feet 2 inches.Initial reporter is an attorney.It is unknown if the complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 had original surgery on (b)(6) 2016, due to a fall, which resulted in a fracture of the left elbow.Patient injuries included a left coronoid fracture with a left radial head fracture.The patient was implanted with one (1) 8mm radial stem, one (1) 20mm radial head and one (1) non-synthes k wire guide.On an unknown date post-operative, the patient presented with pain and limited mobility.The patient was prescribed physical therapy to address the pain and mobility issue.In (b)(6) 2017, thru x-ray, is was observed that the implant appeared lucency, which suggested to a loose implant.On (b)(6) 2017, the surgeon removed the radial head prosthesis implants.It was reported that after the patient had the implants removed, another round of physical therapy was prescribed.Currently, the patient is still suffering from pain as well as limitations in her strength and mobility.Due to the additional surgery to remove the device, the patient is presenting with hastened arthritis issues in her left elbow.Concomitant device: non-synthes wire k wire guide 1.1mm x 5.5in (item: 1600-022, lot: 0416288163, quantity 1).This is report 1 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Code 3191 used to capture required surgical intervention and device removal.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

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.H10 additional narrative: d4: h4: additional information provided.H3, h6: manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: (b)(4), release to warehouse date: (b)(6) 2016; expiration date: february 28, 2021; part: 04.402.008s; 8mm ti straight radial stem 28mm-sterile; lot: h044645; lot quantity: 25.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance supplied by avalign was reviewed and determined to be conforming.Packaging label log lppf was reviewed and determined to be conforming.Sterilization control number (scn) (b)(4) supplied by sterigenics was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part: 21014; tialnbri16.00; lot: 7557656; lot quantity: (b)(4) lbs.Certified test report supplied by (b)(4) company and inspection certificate supplied to (b)(4) were reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Product was not returned.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.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

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.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 two traumas.In 2006 patient sustained a left and right closed wrist fracture, for which she underwent an open reduction internal fixation where unknown plates and screws for fixation.On (b)(6) 2016 patient went to the emergency room (er) due to pain issues from a fall.While at work the patient tripped over a security wire and landed on her elbow.Patient was admitted to the hospital and surgery was performed.Preoperative diagnoses included a left elbow dislocation, left elbow olecranon fracture, left elbow radial head fracture, left elbow coronoid fracture, left wrist distal radial ulnar joint dislocation and shear fracture of the capitellum.During the procedure the surgeon performed a open reduction of left elbow dislocation with an open reduction of internal fixation of olecranon fracture with fluoroscopy imaging.Patient was implanted with a competitors left four (4) hole olecranon plate with five (5) screws, one (1) competitors kwire, and one (1) competitors g wire.These implants were implanted over the olecranon tip.No additional fixation was used.Previous implanted distal radius plate did not appear to have any issues.Patient was placed in splint and ace wrap.On (b)(6) 2016 patient returned to the emergency room present with pain issues.On (b)(6) 2016, patient again returned to the emergency room with reported pain.During this emergency room visit the patient reported with severe pain, left hand fingers swollen with brisk capillary refill.Under x-ray it was noted that the patient¿s elbow was unstable with a dislocated radial head going out posteriorly.Follow up surgery was performed on (b)(6) 2016 with a preoperative diagnoses as; triad injury on top of a olecranon fracture, left elbow instability, left coronoid fracture, left radial head fracture with status post open reduction and internal fixation of left olecranon fracture.During this procedure that surgeon, performed an open reduction of left elbow dislocation, open reduction and internal fixation of left coronoid, removal of painfully hardware, left radial head replacement, repair of left lateral ulnar collateral ligament of the elbow and left elbow replacement.During the procedure it was noted that one of the competitors olecranon plate screws had not quite captured the coronoid fragment and was reported as proud out of the ulna and impinging on the radial head as well.Surgeon removed the proud screw and replaced with another competitors 2.7mm locking screw that held the anteromedial facet in place.Surgeon reported that during this procedure, many fragments were present in the coronoid.There was a tip fragment, a couple of small intercalated fragment, with a separate fragment that appeared to be at the anteromedial facet.Surgeon removed some of the fragments of the intercalated pieces and was able to reduce the anteromedial facet.Surgeon then implanted the patient with a depuy synthes radial head and stem implant.Surgeon also used some of the bone graft from the radial head and packed it around the effect of the coronoid.Surgery was completed successfully.On (b)(6) 2017 patient was returned to surgery with a preoperative diagnoses as constant pain from implanted hardware that was retained in the left wrist and left elbow.Under x-ray it was reported that the depuy synthes radial head prothesis implant appeared very loose.The implant was reported as modular, so a screw was loosened off the radial head, and the head component was removed followed by the stemmed component easily.Surgeon also removed the previously implanted distal radius plate and screws.Post-operatively, patient has followed up with physical therapy appointments to work on patients range of motion.Currently, the patient is still suffering from pain as well as limitations in her strength and mobility.Due to the additional surgery to remove the devices, the patient is presenting with hastened arthritis issues in her left elbow.Concomitant device: competitors wire k wire guide 1.1mm x 5.5in (item # 1600-022, lot # 0416288163, quantity 1 each).Unknown wire g (item number unknown, lot number unknown, quantity 1 each).Unknown wrist plate(item number unknown, lot number unknown, quantity 1 each).Unknown wrist screws (item number unknown, lot number unknown, quantity unknown).Competitors olecranon plate(item number unknown, lot number unknown, quantity 1 each).Competitors screws (item number unknown, lot number unknown, quantity 5 each).

• 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
• MDR Report Key: 7711482
• MDR Text Key: 114755804
• Report Number: 2939274-2018-53025
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128058
• UDI-Public: (01)10886982128058
• Combination Product (y/n): N
• 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: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 04.402.008S
• Device Catalogue Number: 04.402.008S
• Device Lot Number: H04465
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 55