MAUDE Adverse Event Report: DEPUY IRELAND 9616671 LCS COMPLETE M/B PAT CEM LG; KNEE PATELLAR COMPONENT

Catalog Number	129409760
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Necrosis (1971); Pain (1994); Synovitis (2094); Joint Disorder (2373); No Code Available (3191)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
Patient was revised to address loosening of the femur at the bone to cement interface.Depuy cement was used.Update (b)(6) 2017.Medical records reviewed.Primary operative notes (b)(6) 2013 indicate the patient received a left total knee replacement due to osteoarthritis of the left knee.Procedure was completed without complication noted by the surgeon.Office notes (b)(6) 2017 indicate the patient presents due to knee pain as well as a feeling of instability and popping.Revision notes (b)(6) 2017 indicate the patient received a left total knee revision arthroplasty with repair of extensor mechanism to the patella due to failed total knee arthroplasty with loosening of the femoral component.Upon entering the joint, the surgeon notes the patella itself was detached from the proximal portion of the extensor mechanism and attached on distally to the patellar tendon.The patella, aside from the distal pole, was completely loosened from the extensor mechanism and quadriceps tendon and some small remnant of the patella were noted proximally.Presumable were fractures that occurred.The patella component itself was not loose, there was evidence of necrosis of the bone around the superior pole of the patella.It would appear as though this may have been disrupted at some time during the original surgery.The tibial component appeared to be tight, no evidence of loosening.The femoral component revealed evidence of loosening with deep binding of the cement noted in its periphery.A moderate amount of synovitis was also noted and debrided.In an effort to preserve the patient patellar component, #5 fiberwire was passed through the drill holes and base of the peg holes and brought out through the extensor mechanism.Then the patellar component was cemented intro position.The sutures were then tied over the extensor mechanism with a wide soft tissue bridge and cut.The procedure was then completed without complication indicated by the surgeon.Updated (b)(6) 2017.
Additional Manufacturer Narrative
Examination of provided radiographs confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COMPLETE M/B PAT CEM LG
• Common Device Name: KNEE PATELLAR COMPONENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7045796
• Report Number: 1818910-2017-29413
• Device Sequence Number: 13484314
• Product Code: NJL
• UDI-Device Identifier: 10603295022732
• UDI-Public: 10603295022732
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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 Catalogue Number: 129409760
• Device Lot Number: 3624760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 93