MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4 L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-40-400
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Edema (1820); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Injury (2348); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	05/14/2018
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
Depuy sigma litigation record received.Litigation record alleges pain,discomfort, instability,difficulty ambulating, caused by aseptic loosening of smartset ghv bone cement.Doi: (b)(6) 2014.Dor: not reported; left knee.
Event or Problem Description
Medical records received and were reviewed: the depuy patellar component was retained during the left knee revision on (b)(6) 2018.Following the revision, the patient was noted to be experiencing the following adverse symptoms on various dates: pain, stiffness, and swelling.There is no evidence of a second revision nor invasive treatment to address the indicated symptoms involving the retained depuy patellar component and competitor products.
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 : the device associated with this report was not returned to depuy synthes for evaluation.The photo and x-ray investigation found nothing indicative of a device nonconformance or loosening.To confirm the allegation a series of chronological x-rays is needed, therefore the reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: SIGMA PS CEM FEM SZ4 L
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• 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 drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10436931
• Report Number: 1818910-2020-18529
• Device Sequence Number: 19553336
• Product Code: JWH
• UDI-Device Identifier: 10603295075059
• UDI-Public: 10603295075059
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• 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): 01/02/2020

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: 01/31/2023
• Device Model Number: 1960-40-400
• Device Catalogue Number: 196040400
• Device Lot Number: 3558131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 03/31/2021; 02/18/2023
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 04/21/2021; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2013
• 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 4 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP STB TB IN 4 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male