MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ2 RM/LL; EARLY INTERVENTION : KNEE FEMORAL

Model Number 1024-08-200

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

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Primary operative notes (b)(6) 2016 indicate the patient received a right uni knee replacement due to medial compartment osteoarthritis and history of acl injury.The surgery was completed without indication of complication by the surgeon.Office notes (b)(6) 2018 indicate the patient is experiencing increasing pain and difficulty with ambulating.Radiographs reveal a somewhat flexed positioning of the femoral component and anterior translation of the tibial component, lateral compartment osteoarthritis is also present.Revision operative notes (b)(6) 2018 indicate the patient received a conversion to right total knee arthroplasty due to pain and posterior cruciate ligament rupture.Upon entering the knee, it was noted that both components were not worn, in good position and not loose.The knee itself was noted to be unstable posteriorly.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2016.Dor: (b)(6) 2018, right knee.

Manufacturer Narrative

Product complaint # (b)(4).This is a duplicate of 1818910-2020-07272.1818910-2020-09917 is being retracted as it is a report duplication.1818910-2020-07272 will be kept for investigational purposes.

• Brand Name: SIGMA HP UNI FEMORAL SZ2 RM/LL
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9911690
• MDR Text Key: 186746259
• Report Number: 1818910-2020-09917
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295001782
• UDI-Public: 10603295001782
• Combination Product (y/n): N
• PMA/PMN Number: K070849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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 Model Number: 1024-08-200
• Device Catalogue Number: 102408200
• Device Lot Number: C47520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR BONE CEMENT; SIGMA HP UNI A/P SZ2 8MM RMLL
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR