MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT STD+ 12.5MM; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-05-512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
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.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
Lcs components revised for loose joint space and mismatch in flexion/extension gap.Lack of pcl required a ps design to gain more stability.Revised with attune revision was surgery delayed due to the reported event?: no.If yes, number of minutes: approximately 65.Action taken when event occurred?: removed and revised with attune revision.Was procedure successfully completed?: yes.Were fragments generated?: unknown.If yes, were they removed easily without additional intervention?: yes.Patient status/ outcome / consequences: patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?: pain reported.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes.Is the patient part of a clinical study?: unknown.(b)(4): device property of: patient, device in possession of: hospital, (b)(4): device property of: none, device in possession of: none.(b)(4): device property of: patient, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence of the explanted device found that the tibial is fractured at the post.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).A manufacturing records (mre) was not performed.
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
Additional information received.A.Can you please provide the affected side? it is the left knee.B.Was instability related to polyethylene wear or just lack of pcl? lack of pcl.C.Can you confirm, if depuy cement was used, during the primary surgery? if yes, please provide the part and lot numbers of the cement.Quantity of the depuy cement used.Cannot determine.

• Brand Name: LCS COMP RP INSERT STD+ 12.5MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16487967
• Report Number: 1818910-2023-05027
• Device Sequence Number: 5659884
• Product Code: NJL
• UDI-Device Identifier: 10603295022091
• UDI-Public: 10603295022091
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2023

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
• Device Expiration Date: 10/31/2024
• Device Model Number: 1294-05-512
• Device Catalogue Number: 129405512
• Device Lot Number: J6148M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 05/25/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/09/2023; 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY DUOFIX MBT TRAY SZ 3.5; LCS COMPLETE FEM POR L STD+
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female