MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP TROCHLEA SZ3 RT; EARLY INTERVENTION : KNEE FEMORAL

Model Number 1024-04-300

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.This device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2017, the patient had an arthroscopy with lateral release, medical meniscectomy, excision bone spur/osteophyte patella, excision, medial and lateral plica, and chondroplasty, medical femoral condyle, right knee to address bone spur/osteophyte patella, status post patellofemoral arthroplasty, tear of medial meniscus, chondrosis, medial femoral condyle, and medial and lateral plica, right knee.The indications for surgery included increasing pain.Preoperative radiographs were noted to show that the patient had an osteophyte that appeared to be overhanging at the lateral border of his patella.The patient also had slightly tight at the lateral side and the retinacular release may be needed.The patella was noted to reveal no wear and tear.During the procedure the observed a small tear at the medial meniscus that was catching on a grade iii chondral lesion.The patient had normal position of his patellofemoral arthroplasty.The osteophyte was removed.No components were revised at this time.Doi: (b)(6) 2014.Doe: (b)(6) 2017.Right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP TROCHLEA SZ3 RT
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12166578
• MDR Text Key: 261490232
• Report Number: 1818910-2021-15160
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295001683
• UDI-Public: 10603295001683
• Combination Product (y/n): N
• PMA/PMN Number: K061648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-04-300
• Device Catalogue Number: 102404300
• Device Lot Number: 567145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1818910-12/15/2017-004-R
• Patient Sequence Number: 1
• Treatment: DEPUY CMW 2 20G; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA HP TROCHLEA SZ3 RT; DEPUY CMW 2 20G; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA HP TROCHLEA SZ3 RT
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR