MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE

Catalog Number UNK KNEE FEMORAL SLEEVE

Device Problem Osseointegration Problem (3003)

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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 Description

Clinical notification received for revision due to aseptic loosening.Date of implant: (b)(6) 2017.Date of revision: (b)(6) 2023.(left knee).Treatment: femoral component and tibial base were revised.

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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Clinical notes reviewed.On (b)(6) 2017, the patient had a revision left total knee to address loose tibial and femoral components.Depuy components were implanted during this procedure.During the procedure, the surgeon observed that the femoral component was slightly loose.(no mention of what manufacturer¿s components were removed) on (b)(6) 2023, the patient had a total knee revision to address failed left knee replacement.Prior to surgery, the patient reported having pain and instability, and limited function.Radiographs are reported to show a well-fixed, well-aligned tibial component, a loose femoral component, and a large effusion.During the procedure, the surgeon observed that the knee was full of scar tissue.The femoral component was not ingrown in the distal femur.There was scar tissue and fibrinous material connecting the femoral sleeve to the bone.Depuy components along with competitor components were implanted during this procedure.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN KNEE FEMORAL SLEEVE
• Type of Device: KNEE FEMORAL SLEEVE
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17241061
• MDR Text Key: 318265685
• Report Number: 1818910-2023-13517
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SLEEVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 06/12/2023; 07/07/2023
• Supplement Dates FDA Received: 07/05/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PFC*SIGMA DI AUG12MMCO,SZ3LEFT; PFC*SIGMA TC3 FEM LEFT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; TAPER CEM STEM 13X120MM; TC3 RP TIBIAL INSERT S3,15.0; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic