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

Model Number 1024-04-200

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

Patient Problems Adhesion(s) (1695); No Code Available (3191)

Event Date 12/03/2018

Event Type  Injury  

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.

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 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
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9647340
• MDR Text Key: 185429692
• Report Number: 1818910-2020-03558
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295001676
• UDI-Public: 10603295001676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1024-04-200
• Device Catalogue Number: 102404200
• Device Lot Number: 701525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• 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: 46 YR