MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 09.402.022S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Muscular Rigidity (1968); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Reporter is an attorney.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.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 on (b)(6) 2019, the patient underwent a right radial head revision reconstruction, removal of hardware of the olecranon as well as the radial head, lysis of adhesion and debridement and was implanted with a non-synthes device due to a right elbow radial head replacement failure, symptomatic hardware with stiffness and increasing pain.On (b)(6) 2015, the patient has presented discomfort with pain over the right elbow which radiates to the right elbow.The patient fell down on her elbow and sustained a fracture dislocation.She also had nerve symptoms mostly in the ulnar distribution.On (b)(6) 2015, the patient underwent a right olecranon open reduction internal fixation, radial head resection with radial head replacement and open reduction of radial head and was implanted with depuy synthes 20mm diameter head and a 4 hole long right olecranon plate.The patient was diagnosed with right elbow fracture-dislocation, radial head olecranon comminuted fracture and ulnar neurapraxia.On (b)(6) 2016, ct right upper extremity shows plate and screw fixation of the proximal ulna.Comminuted intra-articular fracture now with bridging callus formation.Bridging callus formation is now seen across nondisplaced coronoid process fracture.On (b)(6) 2016, ct shows atrophic nonunion of proximal ulna fracture.On (b)(6) 2017, ct of the upper right extremity shows stable mild loosening of the radial head prosthesis and stable heterotopic ossification of posterior lateral to the radial head prosthesis.Radial head prosthesis with 2 mm zone of lucency surrounding the stem unchanged and suspicious for loosening.On (b)(6) 2019, the patient was diagnosed with a closed fracture of the right olecranon process with nonunion.Also has persistent neck pain and stiffness.The patient presents with complaints of gradual onset.On (b)(6) 2020, ct reveals posterior dislocation of the radial head prosthesis and osteoarthritis.On (b)(6) 2020, the patient underwent a right ulnar nerve decompression, left elbow lysis of adhesion, right elbow removal of hardware of radial head.This report is for one (1) 22mm cocr radial head standard height/12.5mm-sterile.This is report 1 of 10 for (b)(4).

Event Description

Legal and medical records received.On or about (b)(6) 2019, patient experienced displacement, pain, stiffness of right elbow, displaced fracture right, removal of radius head implant, removal of hardware of the olecranon as well as the radial head, lysis of adhesion and debridement.Patient presents due to continued stiffness of the right elbow and worsening right elbow pain.Feels like occupational therapy was vigorous and cause elbow pain to occur after surgery which never resolved.Prior to that session she reports she had wrist pain and numbness which then radiated into the elbow.Ct scan of right elbow was done for review.Reports occasional numbness in the finger.Also has persistent neck pain and stiffness.The patient presents with complaints of gradual onset.This complaint involves (1) device.

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: b5: update.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.H3, h4, h6: device history lot.Part number:09.402.022s.Synthes lot number: 7683418.Supplier lot number: n/a.Release to warehouse date: 06nov2014.Expiration date: 30sep2019.Manufactured by synthes monument.No ncrs were generated during production.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this 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: 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-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: 11251716
• MDR Text Key: 229636712
• Report Number: 2939274-2021-00557
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132598
• UDI-Public: 10886982132598
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 09.402.022S
• Device Catalogue Number: 09.402.022S
• Device Lot Number: 7683418
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Patient Sequence Number: 1
• Treatment: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE; 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE; 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE; 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE; 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/RT/116MM; RAD STEM UNCEM STRAIG SIZ 7 L26 TAN; UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
• Patient Outcome(s): Required Intervention
• Patient Weight: 100