MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® DIST. LATERAL FEMUR PLATE 4.5, 7/9 HOLES, L 243, R; BONE PLATE

Model Number PF 4510-09-2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hip Fracture (2349); Malunion of Bone (4529)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

In the present case, a complex, more fragmentary femur fracture was treated very rigidly.The 85-year-old patient also has influencing comorbities (hta, parkinson).In addition, due to age, it must be assumed that it was no longer possible to control the partial stress of the affected extremity.Clinical expert opinion (university clinic giessen).The supply has always been carried out correctly.From the expert's point of view, too stiff (bridging too short in the area of the fracture zone).The cause of the failure, however, is the lack of healing, which can be clearly seen on the available x-ray images.For example, 6 months after the plate was inserted (post-op), no medial callus formation can be seen on the large spiral fragment.Failure to heal the fracture in combination with a very rigid osteosynthesis may have been the cause of the fracture event.In contrast to joint implants, osteosynthesis plates are only designed for a limited life under load.The lack of bony consolidation thus extended the period of implant loading.This is a late report due to a corrective action.

Event Description

Fracture loqteq® distal.Lateral femur plate after 6 months postoperatively after missing bone consolidation.

• Brand Name: LOQTEQ® DIST. LATERAL FEMUR PLATE 4.5, 7/9 HOLES, L 243, R
• Type of Device: BONE PLATE
• Manufacturer (Section D): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• Manufacturer (Section G): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• Manufacturer Contact: thomas batsch ; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• MDR Report Key: 15670537
• MDR Text Key: 302396668
• Report Number: 3001406084-2020-00030
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K121494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PF 4510-09-2
• Device Catalogue Number: PF 4510-09-2
• Device Lot Number: L012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Race: White