MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE LO PRO POLPAT STD; LCS COMPLETE : KNEE PATELLA

Model Number	1294-09-440
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Adhesion(s) (1695); Cyst(s) (1800); Inflammation (1932); Pain (1994)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Subject id: (b)(6), study: (b)(6).Clinical adverse event received for revision of left patellofemoral arthroplasty to address progressive arthritis and polyethylene bearing wear of patella component.Date of implantation: (b)(6) 2005.Date of revision: (b)(6) 2021; (left knee).Treatment: patellofemoral arthroplasty femur and patella components revised.
Event or Problem Description
On (b)(6) 2021, the patient underwent a left knee revision to address poly wear, pain, cyst on the natural tibia, cystic changes around the patellar component, and fibrous tissue that was debrided around the patella.All partial knee products were revised.The patient was revised with depuy products and competitor cement.There were no indicated intra-operative complications.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b5, h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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: LCS COMPLETE LO PRO POLPAT STD
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11671389
• Report Number: 1818910-2021-07996
• Device Sequence Number: 11553578
• Product Code: NJL
• UDI-Device Identifier: 10603295022503
• UDI-Public: 10603295022503
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-09-440
• Device Catalogue Number: 129409440
• Device Lot Number: 1201000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 05/26/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/22/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS PFJ TROCHLEAR COMP STD LT; SMARTSET HV BONE CEMENT 40G; LCS PFJ TROCHLEAR COMP STD LT; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 64