MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,17.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2354
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Health effect - clinical code: (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
It was reported that this is part of a serial i&d with a poly exchange from the case on (b)(6) 2012 with the following comments listed there: patient has been being treated for chronic infection in gj.Came for further treatment.I&d with poly exchange scheduled.Tibia was loose upon intra-operative evaluation ( sigma mbt w a sleeve and press fit stem - not product numbers or lot numbers).The tibia disengaged from the sleeve but the sleeve did not move.It was decided to clean up the exposed tibia instu and reinsert it with cement on the undersurface.This was due to the poor health and age of the patient.Serial i&ds may be performed.Unknown date or location of insertion of the components.Doi: (b)(6) 2021.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.Should additional information be received, the information will be reviewed and the investigation may 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: TC3 RP TIBIAL INSERT S4,17.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12342436
• Report Number: 1818910-2021-18177
• Device Sequence Number: 19991886
• Product Code: NJL
• UDI-Device Identifier: 10603295242390
• UDI-Public: 10603295242390
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/29/2021

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: 96-2354
• Device Catalogue Number: 962354
• Device Lot Number: H14695
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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); TC3 RP TIBIAL INSERT S4,17.5; UNK KNEE TIBIAL SLEEVE; UNK KNEE TIBIAL TRAY; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); TC3 RP TIBIAL INSERT S4,17.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 89