MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 18MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-118

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Scar Tissue (2060)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #
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> (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the tibial insert was not received for examination.Visual evaluation of the photos attached did not identify any product defects.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 : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the tibial insert was not received for examination.Visual evaluation of the photos attached did not identify any product defects.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 a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: device associated with this report was received for examination and found fine and deep scratching and pitting on the tibial bearing surface and the femoral bearing surface.There was no evidence of embedded debris.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: a worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Corrected: h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : all photographic evidence was reviewed and the device associated with this report was received for examination and found fine and deep scratching and pitting on the tibial bearing surface and the femoral bearing surface.There was no evidence of embedded debris.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 : a worldwide complaint database search found no additional related reports against the provided product code/lot code combination.

• Brand Name: LPS UNIV TIB HIN INS XSM 18MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• 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: 12751110
• MDR Text Key: 280092736
• Report Number: 1818910-2021-24376
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079422
• UDI-Public: 10603295079422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 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?: No
• Device Operator: Health Professional
• Device Model Number: 1987-27-118
• Device Catalogue Number: 198727118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 02/18/2022; 03/29/2022; 05/04/2022; 08/08/2022; 01/13/2023
• Supplement Dates FDA Received: 02/19/2022; 04/01/2022; 05/07/2022; 08/09/2022; 01/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male