MAUDE Adverse Event Report: SYNTHES GMBH UNK - RADIAL HEAD PROSTHESIS; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

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.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown radial head prosthesis/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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

This report is being filed after the review of the following journal article: yagiz ozdag, md., brian foster, md., and louis c.Grandizio, do., (2022), pathologic periprosthetic fracture after radial head arthroplasty a report of 2 cases, the journal of bone and joint surgery, incorporated, volume 12, number 3, pages 1-4 (usa).A report of 2 cases of pathologic periprosthetic radius fractures in the setting of osteolysis after radial head arthroplasty (rha) with a porous-coated, press fit implant (synthes radial head prosthesis).Both patients were managed with implant removal without subsequent instability or disability.Case 1, a 77-year-old woman presented to the outpatient clinic with acute right elbow pain after she felt a "pop" when she tried pulling a table 2 months earlier.She had a history of right rha performed 7 years earlier for a terrible triad injury.Radiographs at that time demonstrated lucency surrounding the rha prosthesis but she had no pain or complaints regarding her elbow.Examination revealed point tenderness of her lateral elbow.Radiographs of the right elbow demonstrated end-stage posttraumatic arthrosis and a peri-implant fracture at the distal tip of the implant.Fig.2 anteroposterior radiographic view of elbow demonstrating the laterally displaced periprosthetic proximal radius fracture.Degenerative changes secondary to osteoarthritis such as marked joint space narrowing and marginal osteophytes can also be seen.The patient was brought to the operating room for hardware removal and examination under anesthesia.Fig.5 the explanted fully porous synthes radial head component that was found to be grossly loose and surgically removed.Fig.6 soft tissue biopsy photomicrograph (x200) showing fibrosis, fibrinous exudate, and granulation tissue.At 6 weeks postoperatively, she reported minimal elbow pain and had returned to previous activities.Case 2, an 87-year-old woman presented to outpatient clinic with acute onset left lateral elbow pain after she felt a "pop" when changing her bed sheet.She had a history of a left rha performed 7 years earlier for a comminuted radial head fracture.Radiographs demonstrated lucency surrounding the rha prosthesis, but she had mild pain without notable restriction activity.Radiographs of the left elbow demonstrated extensive osteolysis and fracture at the distal tip of the prosthesis (figs 3 and 4).Fig.3 anteroposterior radiographic view of elbow demonstrating the laterally displaced periprosthetic fracture of the proximal radius.She was brought to the operating room for hardware removal and examination under anesthesia.The component was found to be grossly loose and removed (fig.5).At 6 weeks postoperatively, she had minimal pain and was able to return to daily activities with minimal discomfort.This report is for an unk - radial head prosthesis.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - RADIAL HEAD PROSTHESIS
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17682810
• MDR Text Key: 322630655
• Report Number: 8030965-2023-11138
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention