MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ3 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-300
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
The patient was revised to address pain in knee.Bone scans/x rays indicated signs of loosening.Surgeon pulled old implants and revised to a new construct.Loosening was reported at tibial and femoral component at bone to cement and cement to implant interface.An unknown bone cement was used.No surgical delay reported.Doi: (b)(6) 2014, dor: (b)(6) 2021, 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.
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: added: d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1.

• Brand Name: SIGMA PS CEM FEM SZ3 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: 11589126
• Report Number: 1818910-2021-06455
• Device Sequence Number: 4781534
• Product Code: JWH
• UDI-Device Identifier: 10603295075134
• UDI-Public: 10603295075134
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1960-50-300
• Device Catalogue Number: 196050300
• Device Lot Number: 7841039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 04/23/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/05/2021; 04/26/2021
• 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: BONE CEMENT(MFG AND PRODUCT NAME UNKNOWN); MBT CEM KEEL TIB TRAY SZ2; PFC SIGMARP STB TB IN 3 10.0; MBT CEM KEEL TIB TRAY SZ2; PFC SIGMARP STB TB IN 3 10.0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 104