MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S3 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Muscular Rigidity (1968); Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
(b)(4) litigation records received.Litigation alleges pain, injuries, loosening of the implant, bone loss, decreased range of motion and diminished mobility.Litigation did not specify the loose component and loosening interface.On (b)(6) 2013, the patient underwent a primary right knee arthroplasty with implantation of depuy products with two depuy cement products.The sticker sheet for products implanted during the primary operation can be found on page 375 of the attached medical records.There were no indicated intra-operative complications.On (b)(6) 2016, the patient underwent a right knee revision due to pain, stiffness, swelling, decreased range of motion, femoral component loosening at both the bone to cement and cement to implant interfaces, and tibial tray loosening at an unknown interface.There were no indicated intra-operative complications.Doi: (b)(6) 2013, dor: (b)(6) 2016, right knee.
Event or Problem Description
The patient was also experiencing difficulty walking due to the right knee prior to the right knee revision on (b)(6) 2016.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for product and/or additional event information, if applicable, will be conducted by the legal group.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specification at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: PFC SIGMARP CV TB/IN S3 15.0
• 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: 10592968
• Report Number: 1818910-2020-20981
• Device Sequence Number: 3819147
• Product Code: NJL
• UDI-Device Identifier: 10603295240761
• UDI-Public: 10603295240761
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2019

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 Expiration Date: 11/30/2017
• Device Model Number: 96-2033
• Device Catalogue Number: 962033
• Device Lot Number: 3540541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 03/30/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 12/17/2020; 04/01/2021
• 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: MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV DOME PAT 3 PEG,32; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV DOME PAT 3 PEG,32; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR