MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT LG 17.5MM; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-05-617
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	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Dair procedure (bearing change and washout) of left lcs tkr involving revision prosthesis details unknown.The procedure appears to be on a previously revised tkr.Sales rep did not attend the case and had limited knowledge of the case and any detail except that the bearing was removed and the knee washout for infection.The implant had stems attached to modular revision lcs femur and mbt rp tibia but no actual details.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not 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.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: LCS COMP RP INSERT LG 17.5MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11486124
• Report Number: 1818910-2021-05098
• Device Sequence Number: 3678941
• Product Code: NJL
• UDI-Device Identifier: 10603295022183
• UDI-Public: 10603295022183
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 1294-05-617
• Device Catalogue Number: 129405617
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: LCS COMP RP INSERT LG 17.5MM; LCS MOD REV CEM FEM LG LT; UNK KNEE TIBIAL TRAY SIGMA (RP) MBT
• Outcome Attributed to Adverse Event: Required Intervention