MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG PS CEM FEM W/LUGS RT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-75-500
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Ecchymosis (1818); Fall (1848); Pain (1994); Joint Laxity (4526); Blister (4537); Swelling/ Edema (4577)
Date of Event	09/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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
It was reported that the patient had total knee replacement done on (b)(6) 2016.His total knee replacement is giving him a pain for the next couple of years and his looking to find out what are the next steps to remediate.Due to his knee locking up, he has fallen and injured.On (b)(6) 2016, the patient underwent a right knee arthroplasty to address degenerative joint disease.Depuy products were implanted with competitor cement (sticker sheet found on page 3 of attached medical records).There were no indicated intra-operative complications.On (b)(6) 2016, the patient underwent a right knee repair of torn quadricep tendon.Prior to the procedure, the patient was experiencing the following adverse symptoms: pain, instability, effusion, bruising to knee, edema, and blisters to right foot managed by wound care.No products were removed.There were no indicated intra-operative complications.Following the repair of right torn quadricep tendon on (b)(6) 2016, the patient continued to experience pain.On (b)(6) 2017, the physician aspirated 16 ml from the right knee to rule out infection.The physician indicated he did not think the fluid appeared infected.There is no evidence of revision following the right quadricep tendon repair.
Event or Problem Description
Imaging report (b)(6) 2020 reveals mild patellar tilt.Patients reports having pain and instability in the knee with some audible clicking.
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: 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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG PS CEM FEM W/LUGS RT SZ5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11372802
• Report Number: 1818910-2021-03732
• Device Sequence Number: 10996558
• Product Code: JWH
• UDI-Device Identifier: 10603295075493
• UDI-Public: 10603295075493
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2020

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 Expiration Date: 04/30/2026
• Device Model Number: 1960-75-500
• Device Catalogue Number: 196075500
• Device Lot Number: C35045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 11/18/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/25/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR CEMENT; COMPETITOR CEMENT; MBT CEM KEEL TIB TRAY SZ5; PFC SIGMARP STB TB IN 5 12.5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG PS CEM FEM W/LUGS RT SZ5; COMPETITOR CEMENT; COMPETITOR CEMENT; MBT CEM KEEL TIB TRAY SZ5; PFC SIGMARP STB TB IN 5 12.5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG PS CEM FEM W/LUGS RT SZ5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 88 KG