MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL; FEMORAL TRIALS

Catalog Number UNK FEMORAL TRIAL

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

Patient Problem Limb Fracture (4518)

Event Date 03/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6).Clinical adverse event received for intraoperative fracture lateral condyle when removing trial : bone fracture - femoral.Event is not serious and is considered mild.There is a remote possibility the ae is related to device and is definitely related to procedure.Date of implantation: (b)(6) 2015, date of event (onset): (b)(6) 2015, affected site: right knee.Treatment: open reduction internal fixation of femur.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot
=
> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK FEMORAL TRIAL
• Type of Device: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13226080
• MDR Text Key: 283616034
• Report Number: 1818910-2022-00621
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FEMORAL TRIAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 01/27/2022
• 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
• Treatment: DEPUY CMW 2G 40G; DEPUY DUOFIX MBT TRAY SZ 3.5; PFC SIG RPF INS SZ 4 12.5MM; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG PS150 FEM COMP SZ 4N R
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 77 KG