MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM CEM L STD; LCS COMPLETE : KNEE FEMORAL

Model Number	1294-02-040
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Date of Event	07/23/2020
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 knee was placed in varus and the patient was unhappy with the result and complained of instability.Revised to attune revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Was the knee malpositioned to offset the patient's anatomy? or was it just not put in correctly? answer: the revising surgeon suspected the tibial resection had been cut at the incorrect angle causing the issue.Was there malpostioning of all the knee components? or just specifically the tibial tray? answer: due to the lcs surgical technique, this also resulted in a slight rotational issue with the femur.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.H10 additional narrative: corrected: h6 (device).The reported device code use of device issue is being corrected to malposition of device to capture the updated coding.

• Brand Name: LCS COMPLETE FEM CEM L STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10362912
• Report Number: 1818910-2020-17472
• Device Sequence Number: 2345265
• Product Code: NJL
• UDI-Device Identifier: 10603295021629
• UDI-Public: 10603295021629
• 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: 2020
• 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): 07/23/2020

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: 1294-02-040
• Device Catalogue Number: 129402040
• Device Lot Number: 8487126
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 08/24/2020; 10/19/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/09/2020; 10/19/2020
• 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 STD 12.5MM; LCS COMPLETE FEM CEM L STD; MBT CEM TIBIAL TRAY SZ2; UNKNOWN BONE CEMENT; LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE FEM CEM L STD; MBT CEM TIBIAL TRAY SZ2; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR