MAUDE Adverse Event Report: SYNTHES GMBH 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number	04.402.007S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Type of Reportable Event	Serious Injury
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is an attorney.H4 device history part # 04.402.007s, synthes lot # 7607058, suppliers lot # na, release to warehouse date: 16 jul 2014, manufactured by: synthes monument.No ncrs were generated during production.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.
Event or Problem Description
It was reported: on or about (b)(6) 2015 the patient suffered a fall, resulting in a radial head fracture in her right arm.On (b)(6) 2015 the patient underwent right radial head arthroplasty and the surgeon implanted a depuy synthes radial head prosthesis system to patient's arm to repair and secure the fracture.On (b)(6) 2021 the patient's physicians determined that the depuy synthes radial head prosthesis system implanted during the 2015 surgery had loosened and was otherwise defective.The patient's right arm failed, loosened and cause degradation of the cortical bone due to a defect in the implant, leading to periprosthetic fractures characteristics of failures with this specific implant.The patient experienced pain, tenderness and discomfort in her right upper extremity.This is report 2 of 2 for (b)(4).This report is for (1)7mm ti straight radial stem 26mm-sterile.

• Brand Name: 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
• Common Device Name: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17001525
• Report Number: 8030965-2023-06631
• Device Sequence Number: 12554705
• Product Code: KWI
• UDI-Device Identifier: 10886982128041
• UDI-Public: (01)10886982128041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 04.402.007S
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 7607058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female