MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS MENIS BEARING SM 12.5MM; LCS : KNEE TIBIAL INSERT

Model Number	1290-02-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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 on an unknown date, 20years before now, the primary surgery was performed via tka with the implants.On an unknown date, it was confirmed that the right bearing implant was dislocated, and the alignment was lost.The patient had difficulty in walking without the cane.On (b)(6) 2021, the revision surgery was performed replacing the bearing implant.
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 : lot information not available.
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
These implants are not be returned.(b)(4).

• Brand Name: LCS MENIS BEARING SM 12.5MM
• Common Device Name: LCS : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11736871
• Report Number: 1818910-2021-08966
• Device Sequence Number: 3832675
• Product Code: NJL
• UDI-Device Identifier: 10603295021056
• UDI-Public: 10603295021056
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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,Followup
• Report Date (Section B): 04/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1290-02-000
• Device Catalogue Number: 129002000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2021
• Supplement Date Received by Manufacturer: 06/02/2021; 06/28/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/03/2021; 06/28/2021
• 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 FEM SM LT; LCS POST CRU RET TIB SM +; LCS ROT PATELLA SM; LCS FEM SM LT; LCS POST CRU RET TIB SM +; LCS ROT PATELLA SM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR