MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; PLATE, FIXATION, BONE

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Date 01/29/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unknown lcp construct/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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: nam, d.J.Et al.(2022), fractures of the distal femur in elderly patients: retrospective analysis of a case series treated with single or double plate, journal of orthopaedic surgery and research, vol.17:55, pages 1-8 ((b)(6)).From may 2004 to june 2018, a total of 82 cases of distal femoral fractures were included in this retrospective study.Group a consisted of 42 patients who underwent single-plate fixation.Group b consisted of 40 patients who underwent double-plate fixation.The mean patient age was 77 years (67¿87 years) and 76 years (64¿86 years) in groups a and b, respectively.The implants used were an lcp and a tomofix-medial distal femur plate.The radiologic results were examined using anterior¿posterior radiography of the distal femur and lateral and oblique radiography at 3, 6, 12, 24 weeks, 1 year, and last follow-up, even after bone union was confirmed.The following complications were reported as follows: group a: 1 case had metal failure and had revision surgery.8 cases had wound infection which was treated with irrigation and debridement.Group b: 1 case had nonunion so autobone graft was performed through revision operation.2 cases had wound infection which was treated with irrigation and debridement.This report is for an unknown lcp construct.This is report 2 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13905384
• MDR Text Key: 293151639
• Report Number: 8030965-2022-01954
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/25/2022
• 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: 02/25/2022
• 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
• Patient Outcome(s): Required Intervention