MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ6 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Not Applicable (3189); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised to address nickel allergy and loosening of unknown component at cement to implant interface.Cement manufacturer is unknown.It was also reported that all implants were explanted and put in knee for hypersensitive nickel allergy.Doi: (b)(6) 2016.Dor: (b)(6) 2018.Right knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.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
Medical records reviewed: on (b)(6) 2016, the patient underwent a primary right knee revision to address osteoarthritis.The patella was resurfaced and depuy products were implanted with depuy cement.There were no indicated intra-operative complications.On (b)(6) 2018, the patient underwent a right knee revision to address pain, metal allergy, and loosening.The surgeon noted the removal of osteophytes on the femur and tibia.Loosening was noted as the pre- and post-operative diagnosis but no specific details were given within the operative note.All products were revised.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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the bone disorder.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 SZ6 R
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7446491
• Report Number: 1818910-2018-57921
• Device Sequence Number: 11250115
• Product Code: JWH
• UDI-Device Identifier: 10603295075172
• UDI-Public: 10603295075172
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2018

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: 03/31/2022
• Device Model Number: 1960-50-600
• Device Catalogue Number: 196050600
• Device Lot Number: 209165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 06/17/2021; 08/18/2021
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/22/2018; 07/05/2021; 08/24/2021
• 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 SZ5; PFC SIGMARP STB TB IN 6 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 136