MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC SIGMARP STB TB IN 4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number 96-2142

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 07/06/2020

Event Type  Injury  

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 Description

It was reported that all components were removed due to septic reasons & a surespace was implanted doi: (b)(6) 2020 (patella,stem, tray), (b)(6) 2020 (insert), unknown (femoral), dor: (b)(6) 2020, left knee.

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.

• Brand Name: PFC SIGMARP STB TB IN 4 12.5
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10290777
• MDR Text Key: 199315764
• Report Number: 1818910-2020-16174
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295241324
• UDI-Public: 10603295241324
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96-2142
• Device Catalogue Number: 962142
• Device Lot Number: 8832118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MBT REVISION CEM TIB TRAY SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA STAB FEMUR SZ 4; UNIVERSAL STEM 75X16MM FLUTED; MBT REVISION CEM TIB TRAY SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA STAB FEMUR SZ 4; UNIVERSAL STEM 75X16MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR