MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DISTAL FEM COMP XSM LT; LPS AND S-ROM : KNEE FEMORAL

Model Number	1987-13-105
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Scar Tissue (2060)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
A phone call was received from a patient today.He stated that on (b)(6) 2020, a piece broke within the lps and a revision was done a couple days later.Doi: not indicated; dor: not indicated; unk knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the tibial insert was not received for examination.Visual evaluation of the photos attached was not able to confirm the complaint.It is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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 material, manufacturing, inspection or sterile processing 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).Investigation summary: the tibial insert was not received for examination.Visual evaluation of the photos attached was not able to confirm the complaint.It is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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 material, manufacturing, inspection or sterile processing 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).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 device associated with this report was received for examination.Femoral component with femoral sleeve exhibited scratching typical of use.However, based on the provided information it is not possible to confirm the implant loosening allegation.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : all photographic evidence was reviewed and the device associated with this report was received for examination.Femoral component with femoral sleeve exhibited scratching typical of use.However, based on the provided information it is not possible to confirm the implant loosening allegation.Depuy synthese 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: LPS DISTAL FEM COMP XSM LT
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12751105
• Report Number: 1818910-2021-24378
• Device Sequence Number: 1441921
• Product Code: JWH
• UDI-Device Identifier: 10603295078685
• UDI-Public: 10603295078685
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K063686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/22/2021

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: 1987-13-105
• Device Catalogue Number: 198713105
• Device Lot Number: J23T32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 02/18/2022; 03/29/2022; 05/04/2022; 08/08/2022; 01/13/2023
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 02/19/2022; 04/01/2022; 05/07/2022; 08/09/2022; 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2019
• 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: LPS DISTAL FEM COMP XSM LT; LPS UNIV TIB HIN INS XSM 18MM; PFC SIGMA TIB TRAY CEM SZ3; SROM*NRH REPL HINGE PIN/XSM/SM; UNIVERSAL FEM SLV FUL POR 40MM; UNIVERSAL STEM 75X22MM FLUTED; LPS DISTAL FEM COMP XSM LT; LPS UNIV TIB HIN INS XSM 18MM; PFC SIGMA TIB TRAY CEM SZ3; SROM*NRH REPL HINGE PIN/XSM/SM; UNIVERSAL FEM SLV FUL POR 40MM; UNIVERSAL STEM 75X22MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male