MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT SZ4; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 due to instability and pain.Surgeon noted loosening of the pfc sigma femoral adapter and pfc sigma bolt.The bolt broke and disassociated from the adapter.The femur was easily removed and the adapter was turned loose.The remaining bolt was removed from the existing femoral sleeve via a threaded extractor in the revision knee removal system.All components were removed.The surgeon then successfully completed converting to a hinge femur.Patient had existing tc3 revision construct in left knee.Doi: (b)(6) 2017, dor: (b)(6) 2021 ,left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12437027
• Report Number: 1818910-2021-19496
• Device Sequence Number: 17573668
• Product Code: JWH
• UDI-Device Identifier: 10603295232506
• UDI-Public: 10603295232506
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 96-0083
• Device Catalogue Number: 960083
• Device Lot Number: H72304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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: PFC SIGMA FEM POST AUG SZ4 8MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DI AUG12MMCO,SZ4LEFT; PFC*SIGMA DIS AUG 4MM,SZ4,LEFT; PFC*SIGMA TC3 FEM LEFT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL FEM SLV FUL POR 31MM; UNK KNEE STEM SIGMA
• Outcome Attributed to Adverse Event: Required Intervention