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

Model Number	1024-04-300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12166697
• Report Number: 1818910-2021-15166
• Device Sequence Number: 3801214
• Product Code: NPJ
• UDI-Device Identifier: 10603295001683
• UDI-Public: 10603295001683
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 08/31/2024
• Device Model Number: 1024-04-300
• Device Catalogue Number: 102404300
• Device Lot Number: 567145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-12/15/2017-004-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR