MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that on an unknown date, the patient was complaining of pain at the distal femur post-operatively.The date of implants is unknown.A removal of hardware from the distal femur was performed on (b)(6) 2022.The surgeon voiced that it was related to irritation of the it band because of the plate.He cut off the distal portion of the va locking plate and removed the screws in that portion of the plate.He wanted to leave the remaining portion even though the patient was healed.The patient did not experience any post-op malfunction.No further information is available.This report involves one unk - plates: 4.5mm va lcp condylar plate.This is report 1 of 7 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.Date of event: only the event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.This report is for an unknown plates: 4.5mm va lcp condylar plate /unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

• Brand Name: UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE
• Type of Device: PLATE, FIXATION, BONE
• 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: 15626573
• MDR Text Key: 301940161
• Report Number: 8030965-2022-08356
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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: 09/28/2022
• 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: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING
• Patient Outcome(s): Required Intervention