MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PFC SIG RPF CEM FEM SZ 2 RT; PFC SIGMA RP-F : KNEE FEMORAL

Catalog Number	950022
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2018
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
The primary surgery was performed via tka with sigma prf implants on (b)(6) 2007.The patient complained the pain after the surgery.The surgeon confirmed that the tibial bone implant was inclined slightly forward due to the bone missing at behind the tibia under x-ray.Also, for the femur side, the gap between the bone in the front flange portion was observed, so that the loosening was occurred at the implant.The revisions surgery was performed on (b)(6) 2018 to replace all implants to another manufacturer¿s implants except for sigma/ov/dome (p/n: (b)(4)).The surgeon decided to keep sigma/ov/dome in the patient¿s knee joint because there was a possibility that it becomes too thin if explanted.No further information was provided by the hospital.
Additional Manufacturer Narrative
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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: PFC SIG RPF CEM FEM SZ 2 RT
• Common Device Name: PFC SIGMA RP-F : KNEE FEMORAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7281882
• Report Number: 1818910-2018-53698
• Device Sequence Number: 164610
• Product Code: NJL
• UDI-Device Identifier: 10603295224082
• UDI-Public: 10603295224082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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: 950022
• Device Lot Number: AH3CF4000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 08/31/2018
• 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