MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA TIB TRAY CEM SZ3; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6023
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2021
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 subsidence and loosening of the tibial component at the cement to implant interface.The patient presented with a sigma knee that was done about 15 years ago.Patient could not provide the exact date.It was reported that it was replaced with a modular plus sigma tibia with a stem and 10 mm medial augment.The surgeon then inserted a curved plus tibial insert.All components were well fixed and knee was stable.Unknown bone cement was used.No surgical delay.Doi: 2005, 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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: PFC SIGMA TIB TRAY CEM SZ3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12303251
• Report Number: 1818910-2021-17544
• Device Sequence Number: 17027126
• Product Code: JWH
• UDI-Device Identifier: 10603295216780
• UDI-Public: 10603295216780
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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
• Report Date (Section B): 07/20/2021

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: 86-6023
• Device Catalogue Number: 866023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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: 3 X 12 CURVED TIBIAL INSERT; PFC SIGMA TIB TRAY CEM SZ3; UNK MANUFACTURER & PRODUCT INFO; 3 X 12 CURVED TIBIAL INSERT; PFC SIGMA TIB TRAY CEM SZ3; UNK MANUFACTURER & PRODUCT INFO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 81