MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG RPF CEM FEM SZ 2 LT; PFC SIGMA RP-F : KNEE FEMORAL

Model Number	95-0012
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2020
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 on (b)(6) 2011 via tka.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the femoral component, the tibial insert and the tibial tray due to loosening of the implants.The femoral implant was inserted by flexed position, and the tibial implant was tilted medial side.The implants were loosed, so the surgeon removed them easily and inserted new implants.The revision surgery was completed without any surgical delay.The surgeon thought that it was technical error by the primary surgery¿s surgeon.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination, however a x-ray images were provided confirming the reported event.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.

• Brand Name: PFC SIG RPF CEM FEM SZ 2 LT
• Common Device Name: PFC SIGMA RP-F : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10482149
• Report Number: 1818910-2020-19245
• Device Sequence Number: 13757635
• Product Code: NJL
• UDI-Device Identifier: 10603295224006
• UDI-Public: 10603295224006
• 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: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2020

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 Model Number: 95-0012
• Device Catalogue Number: 950012
• Device Lot Number: FC7CV4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT CEM KEEL TIB TRAY SZ1.5; PFC SIG RPF INS SZ 2 10MM; MBT CEM KEEL TIB TRAY SZ1.5; PFC SIG RPF INS SZ 2 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 70