MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S5 10.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2051
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/16/2021
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
It was reported that patient was presented with 30 degrees of hyperextension.Revised with a srom hinge system and attune rev rp tray.Doi: (b)(6) 2012.Dor: (b)(6) 2021.Left knee.
Event or Problem Description
Additional information was received stated the following: a.Was there any reported malposition of components that led to the instability? b.Were any components undersized on the primary surgery that led to the instability? c.Was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability? answers: a) no.B) no.C) no.
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.

• Brand Name: PFC SIGMARP CV TB/IN S5 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: 12518444
• Report Number: 1818910-2021-20864
• Device Sequence Number: 20127145
• Product Code: NJL
• UDI-Device Identifier: 10603295240914
• UDI-Public: 10603295240914
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 09/01/2021

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: 96-2051
• Device Catalogue Number: 962051
• Device Lot Number: 3395465
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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: BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN).; MBT CEM KEEL TIB TRAY SZ4.; PFC SIGMARP CV TB/IN S5 10.0.; SIZE 5 CR SIGMA FEMUR.; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP CV TB/IN S5 10.0; SIZE 5 CR SIGMA FEMUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR