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

Model Number	09.402.022S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2015.510k: this report is for an unknown radial head prosthesis/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Reporter is an attorney.Without a lot number the device history records review could not be completed.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.
Event or Problem Description
It was reported that on or about may 16, 2017, the patient underwent an unknown procedure since the system failed and caused pain and severe injury to the patient.On or about december 17, 2015, the patient underwent surgical placement of a synthes radial head prosthesis system on her elbow following an injury.On or about december 2016, synthes announced a recall of the system due to the discovery that the system was defective and could cause the radial stem to loosen post-operatively at the stem bone interface.This report is for one (1) unk - radial head prosthesis.This is report 1 of 2 for (b)(4).
Additional 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.H10: additional narrative: h7, h9.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
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: a1-a5, b6 b7 d1-d4 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
Update: on (b)(6) 2015 patient had a displaced comminuted acute olecranon fracture right elbow and neck fracture.
Additional 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.H10 additional 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
It was reported that on (b)(6) 2015 the patient had a displaced comminuted acute olecranon fracture right elbow which was fixed with a synthes olecranon locking plate, 5 screws in the shaft with bicortical fixation, and 4 locking unicortal screws in the proximal segment.On or about (b)(6) 2016, synthes announced a recall of the system due to the discovery that the system was defective and could cause the radial stem to loosen post-operatively at the stem bone interface.On (b)(6) 2017, the patient underwent revision due to pain, right elbow retained hardware, osteolysis secondary to loose implant - radial head, and failed radial head arthroplasty.Operative findings discovered hyperthropy and synovitis, chondromalacis of capitellum grade ii, grade ii with peripheral spur.The olecranon fracture healed without any loosening or evidence of any osteolysis around olecranon plate and screws this is report 11 of 12 for (b)(4).
Additional 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.H10 additional narrative: 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.Device history lot = > part# 09.402.022s.Synthes lot# 7855833.Supplier lot# n/a.Release to warehouse date: 13 aug2015.Manufactured by: synthes monument.No ncrs were generated during production.Device history batch = > null.Device history review = > review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, 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.B5.

• Brand Name: 22 COCR RADIAL HEAD STD HEIGHT/12.5-SILE
• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10985227
• Report Number: 2939274-2020-05546
• Device Sequence Number: 14526806
• Product Code: KWI
• UDI-Device Identifier: 10886982132598
• UDI-Public: (01)10886982132598
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/13/2020

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: 07/31/2020
• Device Model Number: 09.402.022S
• Device Catalogue Number: 09.402.022S
• Device Lot Number: 7855833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 01/06/2021; 03/25/2022; 04/11/2022; 04/20/2022
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/04/2021; 01/07/2021; 03/30/2022; 04/12/2022; 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM.; UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic