MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 2 10.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2111
Medical Device Problem Codes	Naturally Worn (2988); Unintended Movement (3026); Noise, Audible (3273)
Health Effect - Clinical Codes	Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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) 2004 via tka.It was reported that the patient told something unusual to the surgeon when follow-up in (b)(6) 2020.The surgeon confirmed spin-out by x-ray.An abnormal sound was heard when bend and stretch, and the patient could not bend and stretch smoothly.The patient also had subluxation at ankle joint.The patient rests with spin-out now.The surgeon thought that the spin-out was not caused by the implants at this stage, the reason of spin-out was unknown.He planned to replace the tibial insert for first-line choice, or to replace the tibial insert and the tibial tray for second-line choice since he planned to use a fb tibial insert.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: PFC SIGMARP STB TB IN 2 10.0
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10521909
• Report Number: 1818910-2020-19872
• Device Sequence Number: 19612504
• Product Code: NJL
• UDI-Device Identifier: 10603295241102
• UDI-Public: 10603295241102
• 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: 2004
• 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): 08/26/2020

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: 96-2111
• Device Catalogue Number: 962111
• Device Lot Number: 1209978
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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*SIGMA C/S NPOR FEM RT SZ 2; PFC*SIGMA/OV DOME PAT 3 PEG,32; MBT CEM KEEL TIB TRAY SZ1.5; PFC*SIGMA C/S NPOR FEM RT SZ 2; PFC*SIGMA/OV DOME PAT 3 PEG,32
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR