MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-205

Device Problem Noise, Audible (3273)

Patient Problems Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.It is reasonable to conclude that the tibial insert is not the subject of ¿ and would not cause or contribute to, the reported serious injury of revision due to loosening of the tibial component at the implant to cement interface and/ or bone to cement interface or tibial component subsidence.It is also reasonable to attribute the patient¿s pain limp, difficulty ambulating, swelling, weakness of the leg and limited range of motion to the loosening and scarring.It was noted that scar material was on the extensor mechanism - this scarring is related to the extensor mechanism only and therefore only the femur and patella are coded and reported for scarring as they make up the extensor mechanism.The lateral tilt of the patella is can be assumed to have been caused by the scarring on the extensor mechanism - no indication the patella was mispositioned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Attune medical records received.After review of the medical records the patient was revised to address aseptic loosening of prosthetic of the tibial component, a failed prosthesis with unilateral primary osteoarthritis resulting to chronic pain.Clinical visit showed pretibial soft tissue thickening at about the level of the mid shaft, scattered dystrophic calcification within the soft tissues, pruritis, erythema, weakness right leg, discomfort, residual neurologic deficit in her right leg, soft tissue swelling, tenderness, edema, impaired balance, gait and limited adl.No operative note provided.Doi: (b)(6) 2017.Dor: (b)(6) 2020, right knee.

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: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 (mrae) was not performed.

• Brand Name: ATTUNE PS FEM RT SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12839348
• MDR Text Key: 281008747
• Report Number: 1818910-2021-25636
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295041764
• UDI-Public: 10603295041764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-10-205
• Device Catalogue Number: 150410205
• Device Lot Number: 8449007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• 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: ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 7MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic