MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Occupation is unknown as the information for the event is provided by consumer.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
This complaint is to capture the event reported in (b)(4).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.There is no evidence of confirmed infection within the available medical records.Doi: (b)(6) 2016, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : update 19-apr-2021: the investigation was re-opened upon receipt of additional information.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.
Event or Problem Description
Additional information received indicated that the patient continued to experience pain in the right pain.Oral medication and continued physical therapy were noted as treatment.There was no indication of additional invasive intervention or device revision at this time.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PFC SIGMARP STB TB IN 5 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11392288
• Report Number: 1818910-2021-03983
• Device Sequence Number: 1283730
• Product Code: NJL
• UDI-Device Identifier: 10603295241393
• UDI-Public: 10603295241393
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/17/2021

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: 06/30/2020
• Device Model Number: 96-2152
• Device Catalogue Number: 962152
• Device Lot Number: 8152031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 04/14/2021; 04/29/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/09/2021; 04/21/2021; 04/30/2021
• 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: COMPETITOR CEMENT; COMPETITOR CEMENT; MBT CEM KEEL TIB TRAY SZ5; 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*SIGMA/OV/DOME PAT 3PEG,38; SIG PS CEM FEM W/LUGS RT SZ5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 88