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

Model Number	1960-40-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Revision left total knee replacement.Primary knee done 12 months ago on (b)(6) 2020 with pfc fixed bearing construct.No depuy cement was used in primary case.If other, describe: revision total knee replacement left knee, did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing?yes, did the patient require revision surgery or hardware removal? yes, facility name of original implant: cairns private hospital, was device explanted? true, hardware/explant removal due to: pain & instability, did patient require revision surgery? true, if yes, date of revision surgery.On (b)(6) 2021, reason for revision surgery: pain & instability of left knee, patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? pain, instability, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe: revision total knee surgery, is the patient part of a clinical study: no, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.
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 L
• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12470643
• Report Number: 1818910-2021-20072
• Device Sequence Number: 11731056
• Product Code: JWH
• UDI-Device Identifier: 10603295075059
• UDI-Public: 10603295075059
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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 Model Number: 1960-40-400
• Device Catalogue Number: 196040400
• Device Lot Number: 8427321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 4; SIGMA PS CEM FEM SZ4 L; SIGMA STAB XLK INS 4 12.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 85 KG