MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 LCS COMP RPSFLEX FEM CEM R LG; LCS COMPLETE : KNEE FEMORAL

Catalog Number	129411060
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/05/2018
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
Der states that the surgeon discovered signs of metallosis in the soft tissue joint space intra-operatively.Femur prosthesis was also discovered to be aseptically loose.Cultures were sent to pathology.Surgeon does not believe there are deficiencies in the design of the implant.No implants are being returned.Doi: (b)(6) 2009, dor: (b)(6) 2018, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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 COMP RPSFLEX FEM CEM R LG
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7319745
• Report Number: 1818910-2018-54645
• Device Sequence Number: 18862045
• Product Code: JWH
• UDI-Device Identifier: 10603295022879
• UDI-Public: 10603295022879
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 129411060
• Device Lot Number: 2597303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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: 69 YR