MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA FEM POST AUG SZ2 8MM; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0828
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed due to infection and loosening of the tibial tray at the bone to cement interface and loosening of the femoral component at the bone to implant interface.Two depuy cements were used.Implants were removed and insertion of antibiotic spacer was performed.Doi: (b)(6) 2015.Dor: (b)(6) 2022.Affected side: right knee.
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.
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: PFC SIGMA FEM POST AUG SZ2 8MM
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14103983
• Report Number: 1818910-2022-06713
• Device Sequence Number: 6229510
• Product Code: JWH
• UDI-Device Identifier: 10603295234111
• UDI-Public: 10603295234111
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 96-0828
• Device Catalogue Number: 960828
• Device Lot Number: 477223
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• 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: MBT REV TIB TRAY SIZE 3 15MM.; MBT TRAY SLEEVE POR M/L 29MM.; PFC SIGMA FEM POST AUG SZ2 8MM.; PFC*SIGMA DIS AUG 4MM,SZ2,RGHT.; PFC*SIGMA DIS AUG 4MM,SZ2,RGHT.; PFC*SIGMA DIS AUG 8MM,SZ2,RGHT.; PFC*SIGMA TC3 FEM RT SZ2.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; SMARTSET HV BONE CEMENT 40G.; SMARTSET HV BONE CEMENT 40G.; TC3 RP TIBIAL INSERT S2,15.0.; UNIVERSAL FEM SLV FUL POR 34MM.; UNIVERSAL STEM 75X16MM FLUTED.; UNIVERSAL STEM 75X18MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 70 KG