MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG 1PST RD/DOME PAT 38MM; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number	98-6038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	01/04/2016
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
Patient underwent a left sigma tka with depuy cement.He was then revised on (b)(6) 2016 for pain and loosening of the tibial tray at the implant to cement interface.Surgeon also noted patient had a significant flexion contracture of 25 degrees.The tray and insert were revised only.Doi: (b)(6) 2014, dor (tray and insert only): (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 no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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.Retracting the reported explant date in d6b since the device was not revised.
Event or Problem Description
In addition to the previously reported adverse symptoms the patient was also experiencing left knee stiffness.On (b)(6) 2020, the patient presented to the emergency department due to difficulty breathing.Troponin level of 0.3 ng/ml and started on iv heparin drip.Multiple iv medications were administered- solu-medrol, metroprolol, and lasix as well as oral aspirin, potassium, and magnesium.The patient was placed on cpap and transferred to the tele unit before being transferred to a different hospital.The patient appeared to have a long history of cardiac, pulmonary, and renal issues not related to any depuy product.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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: PFCSIG 1PST RD/DOME PAT 38MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9575124
• Report Number: 1818910-2020-01447
• Device Sequence Number: 16904675
• Product Code: JWH
• UDI-Device Identifier: 10603295253129
• UDI-Public: 10603295253129
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/12/2019

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: 11/30/2018
• Device Model Number: 98-6038
• Device Catalogue Number: 986038
• Device Lot Number: D13114050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 08/06/2020; 09/03/2020; 03/17/2021; 11/23/2021
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 08/23/2020; 09/08/2020; 04/07/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2014
• 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 SIGMARP STB TB IN 3 10.0; SIGMA PS CEM FEM SZ3 L; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male