MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 4 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-14-108
Medical Device Problem Codes	Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fall (1848); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	01/02/2020
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
Patient correspondence: patient contacted depuy stating he is experiencing "snapping" at his knee joint when walking and when raising his leg.
Event or Problem Description
Medical records received were reviewed by a clinician to identify product issues and/or patient harms.Patient received left primary pfc sigma tka to treat degenerative joint disease of the left knee.The patella was resurfaced, and depuy cement x 2 was utilized.The procedure was completed without reported complications.Primary implant sticker sheet is available on page 11 of the medical records.On (b)(6) 2014, the patient sent a letter to depuy with complaints of a ¿snapping¿ in the knee joint when moving.On (b)(6) 2020, the patient sent a letter to depuy with complaints of pain, emotional distress, and, ¿being restricted in what and how¿ he could accomplish daily tasks.Records indicate the patient was revised due to pain.Upon entering the knee, the surgeon identified and excised pericapsular scar tissue before removing the tibial insert.The femoral component, patella, and tibia were all revised due to loosening at an unknown interface.The patient was then implanted with depuy revision knee components utilizing unknown cement.The procedure was completed without complications.Doi: (b)(6) 2014, dor: (b)(6) 2020 left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative: added: b5, b7, h6 (no code available (3191) is used to capture the minor injury and emotional distress).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
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: dhr performed as part of this legacy complaint investigation under (b)(4).Product code: 158114108, work order: (b)(4) was manufactured on 09 may 2014.24 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.

• Brand Name: SIGMA CRVD XLK INS 4 8MM
• 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: 9767463
• Report Number: 1818910-2020-06323
• Device Sequence Number: 2330484
• Product Code: JWH
• UDI-Device Identifier: 10603295063506
• UDI-Public: 10603295063506
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2015

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 Expiration Date: 04/30/2019
• Device Model Number: 1581-14-108
• Device Catalogue Number: 158114108
• Device Lot Number: 7900044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 09/08/2021
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/08/2020; 09/08/2021
• 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 MOD TIB TRAY CEM SZ4.; PFC*SIGMA C/R NPOR FEM LT SZ5.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIGMA CRVD XLK INS 4 8MM.; SMARTSET HV BONE CEMENT 40G.; SMARTSET HV BONE CEMENT 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR