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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER Back to Search Results
Model Number 04.402.007S
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) 7mm ti straight radial stem 26mm-sterile.This is report 3 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.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:04.402.007s, synthes lot number: 7838214, supplier lot number: n/a, release to warehouse date: 06apr2015, expiration date: 28feb2020, 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.
 
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Brand Name
7MM TI STRAIGHT RADIAL STEM 26MM-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 Key11251872
MDR Text Key229412405
Report Number2939274-2021-00561
Device Sequence Number1
Product Code KWI
UDI-Device Identifier10886982128041
UDI-Public10886982128041
Combination Product (y/n)N
PMA/PMN Number
K112030
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2020
Device Model Number04.402.007S
Device Catalogue Number04.402.007S
Device Lot Number7838214
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/08/2021
Initial Date FDA Received01/29/2021
Supplement Dates Manufacturer Received02/25/2021
Supplement Dates FDA Received03/02/2021
Removal/Correction NumberZ-1124-2017
Patient Sequence Number1
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; UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; 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; UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
Patient Outcome(s) Required Intervention;
Patient Weight100
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