MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RPS INS STD 10MM; LCS COMPLETE : KNEE TIBIAL INSERT

Model Number	1294-16-410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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
Revision total knee patella resurfacing for patella femoral pain.Large osteophyte (ectopic bone) at superior edge of anterior trochlear.Ectopic bone appears to have developed over time.The patient presented with anterior knee pain.The patients patella was resurfaced and the ectopic bone removed.All of the knee components listed were all left insitu.Primary surgery date (b)(6) 2009.
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 indicated that none of the implants were revised.The patients patella was resurfaced and the ectopic bone removed.None of the knee components listed required revision and were all left in situ.As this was a revision procedure there was no extension to the surgical time.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LCS COMP RPS INS STD 10MM
• 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: 12041129
• Report Number: 1818910-2021-13248
• Device Sequence Number: 4000675
• Product Code: NJL
• UDI-Device Identifier: 10603295023173
• UDI-Public: 10603295023173
• 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 Implanted Year: 2009
• 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,Followup
• Report Date (Section B): 06/08/2021

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: 1294-16-410
• Device Catalogue Number: 129416410
• Device Lot Number: CL2KP4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/21/2021; 07/05/2021; 08/04/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 06/28/2021; 07/14/2021; 08/06/2021
• 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: CEMENT MFG AND PRODUCT NAME UNKNOWN; DEPUY DUOFIX MBT TRAY SZ 2.5; LCS COMP RPS INS STD 10MM; LCS COMP RPSFLEX FEM CEM L STD; DEPUY DUOFIX MBT TRAY SZ 2.5; LCS COMP RPS INS STD 10MM; LCS COMP RPSFLEX FEM CEM L STD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR