MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP TROCHLEA SZ2 RT; EARLY INTERVENTION : KNEE FEMORAL

Model Number	1024-04-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); No Code Available (3191)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Knee claim record received.Claim record alleges failed patellofemoral arthroplasty.Depuy cement was used.Primary operative notes (b)(6) 2016 indicate the patient received a right knee patella femoral arthroplasty due to patellafemoral arthritis.Revision operative notes (b)(6) 2018 indicate the patient received a right patella femoral knee revision with implantation of competitor right total knee due to failed patella femoral knee arthroplasty.Upon entering the joint, hypertrophic scarring is encountered along with osteophytes along the femoral component, scaring and osteophytes removed.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6).Dor: (b)(6).Right knee.

• Brand Name: SIGMA HP TROCHLEA SZ2 RT
• Common Device Name: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9647340
• Report Number: 1818910-2020-03558
• Device Sequence Number: 19616830
• Product Code: HRY
• UDI-Device Identifier: 10603295001676
• UDI-Public: 10603295001676
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K061648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 09/30/2025
• Device Model Number: 1024-04-200
• Device Catalogue Number: 102404200
• Device Lot Number: 701525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR