MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG RPF AOX INS SZ 5 17.5MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Catalog Number	196191053
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2019
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 patient was revised to address loosening of the femoral component at cement to implant interface.Unknown cement was used.It was also reported that the sigma rpf femur and insert removed due to being oversized and possibly loose.The femur was loose with no contact of an implant to anterior and posterior faces.The component was too large for the patient.No infection present.Re-implanted to tc3 with cemented stem and tc3 insert.Mbt revision tray from original surgery was retained.Doi: (b)(6) 2016; dor: (b)(6) 2019, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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 will be filed as appropriate.

• Brand Name: SIG RPF AOX INS SZ 5 17.5MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8601551
• Report Number: 1818910-2019-93213
• Device Sequence Number: 16646928
• Product Code: NJL
• UDI-Device Identifier: 10603295075998
• UDI-Public: 10603295075998
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 196191053
• Device Lot Number: 230160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: 71 YR