MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMP VVC INS STD+ 20MM; LCS REVISION : KNEE TIBIAL INSERT

Model Number	1294-24-520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); No Code Available (3191)
Date of Event	07/16/2019
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
Primary implanted on (b)(6) 2012.Reason for revision: malalignment.Patient had the above implants in situ.Tkjr revision performed as implants malaligned and osteolysis present.No further comment from surgeon.Implants removed, specimens take to rule out infection.J&j rep was present at the case.Tc3 implants implanted.Impacted products: 1 x d129424520; lcs comp vvc ins std+ 20mm; lot no: unknown; 1 x lcs std + femur -unknown jrn; 1 x d129435130c ; mbt revision cem tib tray sz 3 ; lot no:fh8jl1; 1 x d11082083; unknown jrn.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present.Root cause undetermined.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative: added: h6 (no code available (3191) is used to capture the medical device removal).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: LCS COMP VVC INS STD+ 20MM
• Common Device Name: LCS REVISION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8861805
• Report Number: 1818910-2019-100087
• Device Sequence Number: 19317175
• Product Code: NJL
• UDI-Device Identifier: 10603295024750
• UDI-Public: 10603295024750
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2019

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: 1294-24-520
• Device Catalogue Number: 129424520
• Device Lot Number: E5DG44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 10/01/2019; 01/22/2020
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/08/2019; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR