MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE M/B PAT POR LG+; LCS COMPLETE : KNEE PATELLA

Model Number	1294-09-670
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Synovitis (2094); No Code Available (3191)
Date of Event	08/25/2020
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
Patient experienced "sudden onset of pain" in the knee a few weeks ago and was reviewed by doctor.The doctor suspected there was an issue with the insert and elected to do a revision to replace the primary insert (he felt it may be fractured or cracked).Upon opening the knee there was no obvious damage to the insert, and doctor felt the implant was in reasonably good condition in his opinion, but there was some damage to the patella button (cause unknown).There was significant synovitus surrounding the joint.Surgeon debrided the affected tissue and replaced the insert and patella button.No details were available regarding the mechanism that lead to the onset of pain (no mention of fall or other injury given).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the attached photographs identified tibial insert, guide arm and patella products.It was noted that the patella product was de-laminated/fractured.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : (b)(4) pieces were manufactured per specification.(b)(4) piece was scrapped for a laser mark on the porocoat.

• Brand Name: LCS COMPLETE M/B PAT POR LG+
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10521652
• Report Number: 1818910-2020-19865
• Device Sequence Number: 3055808
• Product Code: NJL
• UDI-Device Identifier: 10603295022671
• UDI-Public: 10603295022671
• 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: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-09-670
• Device Catalogue Number: 129409670
• Device Lot Number: 3185118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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 APG INSERT LG+ 10MM; LCS COMP APG INSERT LG+ 10MM
• Outcome Attributed to Adverse Event: Required Intervention