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

Model Number	1024-08-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9911690
• Report Number: 1818910-2020-09917
• Device Sequence Number: 16999997
• Product Code: HRY
• UDI-Device Identifier: 10603295001782
• UDI-Public: 10603295001782
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K070849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: 1024-08-200
• Device Catalogue Number: 102408200
• Device Lot Number: C47520
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR BONE CEMENT; SIGMA HP UNI A/P SZ2 8MM RMLL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR