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); Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2017

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.(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

On (b)(6) 2017, the patient had a right arthroscopy, incision and drainage of the right knee to address persistent right knee drainage status post arthroscopy and lateral release.The indications for surgery noted that the patient had recently had an arthroscopy lateral release and removal of an osteophyte for persistent pain, status post patellofemoral arthroplasty.The patient presented with persistent drainage and it was felt that an i&d with cultures and antibiotic was indicated to prevent the possibility of infecting his pre-existing prothesis.No components revised.Post operatively, the 48 hour cultures were negative for infection.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 synthese 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: 12166697
• MDR Text Key: 261484766
• Report Number: 1818910-2021-15166
• 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