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

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Osteolysis (2377)

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown radial head prosthesis/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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

This report is being filed after the review of the following journal article: corbaz j, barimani b and vauclair f.,(2023), early aseptic loosening of a press-fit radial head prosthesis ¿ a case series of 6 patients, journal of international medical research, vol.51(4) pages 1-9,(switzerland).This retrospective study aims to present six cases of failed rha using a modular monopolar press-fit rha that was subsequently withdrawn from the market because it was associated with a high incidence of loosening.Between july 2015 and june 2016, six patients received radial head prosthesis system, depuy synthes- johnson & johnson, new brunswick, new jersey, usa), the average age of the five men and one woman was 47 years (range 27-63 years).The average follow up was 40 months.The following complications were reported as follows: x-rays showed the presence and progression of osteolysis around the stem in five (83%) cases.In these five cases, the osteolysis progressed around the stem, culminating with a loose stem 6-12 months following surgery (fig.4) four of the cases were symptomatic (i.E., pain during loading of the elbow) and removal of the prosthesis was conducted in these patients.Removal of the prosthesis allowed clear regression of elbow pain, and subsequently three patients reported a pain free elbow with the exception of one patient who complained of mild exertional pain when gardening or snow shovelling.This report is for an unknown synthes radial head prosthesis system.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17634467
• MDR Text Key: 322092653
• Report Number: 8030965-2023-10846
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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