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

Model Number	1960-50-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
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.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
Spoke with patient on phone today (b)(6) 2022.Patient states his primary was done in munster, in on (b)(6)2019 with depuy implants.He has now had a revision on (b)(6) 2022.He states the tray was tilted and prior to the revision, he had pain and difficulty walking.Part/lot provided of the femoral and insert are below.He did not have any information regarding the tray.He then requested compensation and his information has been forwarded to legal (see (b)(4) legal notification).He was also provided the contact information of the legal paralegal.He has no further needs at this time.Doi: (b)(6) 2019.Dor: (b)(6) 2022.Unknown side.
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: 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Upon further review, it has been determined that there is no allegation against the device, no reportable event as the surgeon elected not to revise the femoral component.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: SIGMA PS CEM FEM SZ4 R
• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15311819
• Report Number: 1818910-2022-16828
• Device Sequence Number: 19481695
• Product Code: JWH
• UDI-Device Identifier: 10603295075141
• UDI-Public: 10603295075141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 08/29/2022

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 Model Number: 1960-50-400
• Device Catalogue Number: 196050400
• Device Lot Number: 8762566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 08/30/2022; 10/28/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/01/2022; 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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: SIG RP AOX STB INS SZ4 12.5; SIGMA PS CEM FEM SZ4 R; UNKNOWN KNEE IMPLANT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown