MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP CONDYLAR PLATE 4.5/5.0 LE 14HO L3; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.415

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

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.H10 additional narrative: d2b.Procode: hrs, hwc.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device evaluated by mfr, device manufacture date, 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

Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2023, the left condylar support plate is placed on the right femur.Leaving the distal part of the plate in the proximal femur, without affecting the patient.This report is for one (1) 4.5mm va-lcp curved condylar plate/14 hole/301mm/left.This is report 1 of 1 for complaint: (b)(4).

• Brand Name: VA-LCP CONDYLAR PLATE 4.5/5.0 LE 14HO L3
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: 16782138
• MDR Text Key: 313843819
• Report Number: 8030965-2023-05044
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454118
• UDI-Public: (01)07611819454118
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/20/2023
• 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
• Treatment: UNK - SCREWS: TRAUMA