MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA PS CEM FEM SZ2 L; KNEE FEMORAL COMPONENT

Catalog Number	196040200
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	07/20/2017
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.
Event or Problem Description
Patient was revised to address pain and loosening of the femoral component.Loosening interface occur at the bone to cement and cement to implant.Cement manufacturer is competitor.It was also reported that half of the femur had no cement applied to bone or implant.
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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: SIGMA PS CEM FEM SZ2 L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6804706
• Report Number: 1818910-2017-23156
• Device Sequence Number: 1853347
• Product Code: JWH
• UDI-Device Identifier: 10603295075028
• UDI-Public: 10603295075028
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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: 196040200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/05/2017
• 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: 59 YR