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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/10/2017
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.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 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.
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 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: 12166578
• Report Number: 1818910-2021-15160
• Device Sequence Number: 11712612
• 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: 08/16/2021
• 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