MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S3 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Muscular Rigidity (1968); Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
Sigma 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) 2011, the patient underwent a primary left knee arthroplasty with implantation of depuy products.The sticker sheet for products implanted during the primary operation can be found on page 1015 of the attached medical records.The cement used during the primary operation is not given in the available medical records.There were no indicated intra-operative complications.On (b)(6) 2017, the patient underwent a left knee revision due to pain, baker¿s cyst, stiffness, decreased range of motion, femoral component loosening at an unknown interface, and tibial tray migration and loosening at the cement to implant interface.There were no indicated intra-operative complications.Doi: (b)(6) 2014.Dor: (b)(6) 2017; left knee.
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.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 S3 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10606461
• Report Number: 1818910-2020-21213
• Device Sequence Number: 11461506
• Product Code: NJL
• UDI-Device Identifier: 10603295240754
• UDI-Public: 10603295240754
• 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: 2011
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• 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: 02/29/2016
• Device Model Number: 96-2032
• Device Catalogue Number: 962032
• Device Lot Number: 3269581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 07/15/2022
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 12/16/2020; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT CEM KEEL TIB TRAY SZ3.; PFC*SIGMA C/R NPOR FEM LT SZ 3.; PFC*SIGMA/OV DOME PAT 3 PEG,32.; UNKNOWN BONE CEMENT.; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA/OV DOME PAT 3 PEG,32; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female