MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA FEM STEM BOLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960770
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
It was stated a total knee revision performed on (b)(6) 2018.The sigma 0 mm bolt came loose at some point as a result of the one piece 7 degree femoral stem breaking.Revised to a lps distal femoral replacement.Loosening occurred from bone to cement interface.Cement manufacturer competitor.Doi: 2009; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMA FEM STEM BOLT
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7302815
• Report Number: 1818910-2018-54295
• Device Sequence Number: 13888613
• Product Code: JWH
• UDI-Device Identifier: 10603295233893
• UDI-Public: 10603295233893
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 960770
• Device Lot Number: 302802
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018; 11/28/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 02/28/2018; 11/29/2018
• 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: 73 YR
• Patient Weight: 75