MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA DIS AUG8MM,S2.5,LEFT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0842
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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
Patient was revised to treat pain and infection.Patient received a two-stage revision.Doi: (b)(6) 2021.Dor: (b)(6) 2021; unk 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12225881
• Report Number: 1818910-2021-16022
• Device Sequence Number: 12027215
• Product Code: JWH
• UDI-Device Identifier: 10603295234180
• UDI-Public: 10603295234180
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 96-0842
• Device Catalogue Number: 960842
• Device Lot Number: 483960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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: COMPETITOR CEMENT; PFC SIG FEM POST AUG SZ2.5 4MM; PFC SIG FEM POST AUG SZ2.5 4MM; PFC*SIGMA DIS AUG8MM,S2.5,LEFT; PFC*SIGMA TC3 FEM LEFT S2.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S2.5,25.0; UNIV FEM SLEEVE CEM 20MM; UNIVERSAL STEM 75X14MM FLUTED; UNK KNEE TIBIAL TRAY SIGMA (RP) MBT; COMPETITOR CEMENT; PFC SIG FEM POST AUG SZ2.5 4MM; PFC SIG FEM POST AUG SZ2.5 4MM; PFC*SIGMA DIS AUG8MM,S2.5,LEFT; PFC*SIGMA TC3 FEM LEFT S2.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S2.5,25.0; UNIV FEM SLEEVE CEM 20MM; UNIVERSAL STEM 75X14MM FLUTED; UNK KNEE TIBIAL TRAY SIGMA (RP) MBT
• Outcome Attributed to Adverse Event: Required Intervention