MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RAD STEM UNCEM STRAIG SIZ 7 L26 TAN; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.007S

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Muscle/Tendon Damage (4532)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2015.510k: this report is for an unknown radial head prosthesis: radial stem/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 Description

It was reported that on or about (b)(6) 2017, the patient underwent an unknown procedure since the system failed and caused pain and severe injury to the patient.On or about (b)(6) 2015, the patient underwent surgical placement of a synthes radial head prosthesis system on her elbow following an injury.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.This report is for one (1) unk - radial head prosthesis: radial stem.This is report 2 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.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.

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 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 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.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 12 of 12 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.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 # 04.402.007s, synthes lot # 7855590, supplier lot # n/a, release to warehouse date: 30 apr 2015, expiration date: 01 mar 2020, manufacturing location: monument , no ncr's 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.

Event Description

Update: on (b)(6) 2015 patient had a displaced comminuted acute olecranon fracture right elbow and neck fracture.

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: b5, g4 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: RAD STEM UNCEM STRAIG SIZ 7 L26 TAN
• 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
• 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: 10985274
• MDR Text Key: 220727487
• Report Number: 2939274-2020-05547
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 07611819511057
• UDI-Public: (01)07611819511057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 7855590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: UNK - RADIAL HEAD PROSTHESIS.; UNK - RADIAL HEAD PROSTHESIS
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Ethnicity: Non Hispanic