MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 INS 15MM, SZ2; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-0512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/14/2020
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
Revised due to subsidence and the patient¿s anatomy.The initial revision was performed in (b)(6) of 2016.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Usfda mdr determination: after reviewing with the knee investigator and fellow clinician, the patient was revised due to subsidence.It is reasonable to conclude the pfc sigma tc3 ins 15mm, sigma fem adapter neutral bolt, sigma fem adapter 5 degree, didn't cause or contribute to the subsidence as it doesn't have any contact with the bone.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10748329
• Report Number: 1818910-2020-23437
• Device Sequence Number: 11600216
• Product Code: JWH
• UDI-Device Identifier: 10603295232988
• UDI-Public: 10603295232988
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 96-0512
• Device Catalogue Number: 960512
• Device Lot Number: FL1FT4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: PFC SIGMA INSET PAT 32MM.; PFC* MOD PLUS TIBIAL TRAY SZ 2.; PFC*MOD PL TB WDG STP 1OMM SZ2.; PFC*SIGMA DIS AUG 8MM,SZ2,RGHT.; PFC*SIGMA TC3 FEM RT SZ2.; PFC*SIGMA TC3 INS 15MM, SZ2.; SIGMA FEM ADAPTER 5 DEGREE.; SIGMA FEM ADAPTER NEUTRAL BOLT.; UNIVERSAL STEM 75X14MM FLUTED.; UNIVERSAL STEM 75X16MM FLUTED.; PFC SIGMA INSET PAT 32MM; PFC* MOD PLUS TIBIAL TRAY SZ 2; PFC*MOD PL TB WDG STP 1OMM SZ2; PFC*SIGMA DIS AUG 8MM,SZ2,RGHT; PFC*SIGMA TC3 FEM RT SZ2; PFC*SIGMA TC3 INS 15MM, SZ2; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; UNIVERSAL STEM 75X14MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention