MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.Dmf# - (b)(4): trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form ¿ powder, strength ¿ 1.0g active in our cements.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
Knee litigation record received.Litigation record alleges pain, discomfort, instability, difficulty ambulating and aseptic loosening of the tibial component at an unknown interface.Depuy cement was used.Doi: (b)(6) 2015, dor: (b)(6) 2018, right knee.Additional information: 12/17/2020: surgeon uses depuy 2 ((b)(4)) or depuy 2 with gent ((b)(4)) based on patient.He would have likely used 2 batches which is his norm.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 PS CEM FEM SZ4 R
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11083532
• Report Number: 1818910-2020-27694
• Device Sequence Number: 3260715
• Product Code: JWH
• UDI-Device Identifier: 10603295075141
• UDI-Public: 10603295075141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1960-50-400
• Device Catalogue Number: 196050400
• Device Lot Number: 8099640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 04/29/2021; 07/09/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 05/17/2021; 07/12/2021
• 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: MBT CEM KEEL TIB TRAY SZ4; PFC SIGMA RD DOME PAT 3PEG 38; PFC SIGMARP STB TB IN 4 10.0; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR