MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA TC3 FEM RT SZ2; SIGMA REVISION IMPLANT : KNEE FEMORAL

Catalog Number	866468
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Naturally Worn (2988)
Health Effect - Clinical Codes	Tissue Damage (2104); Not Applicable (3189)
Date of Event	07/11/2018
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
Patient was revised to address metallosis and loosening of the stem bolt and femur at the cement to implant interface.Unknown cement was used.It was also reported that the patient underwent poly swap since doing the revision.Doi: (b)(6) 2001; dor: (b)(6) 2018; right knee.
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.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7756934
• Report Number: 1818910-2018-65903
• Device Sequence Number: 13892389
• Product Code: JWH
• UDI-Device Identifier: 10603295232544
• UDI-Public: 10603295232544
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 866468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 11/27/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/04/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR