MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 8 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-108

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Osteolysis (2377); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: (b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(4) medical records ad (b)(6) 2022 were reviewed by clinician.On (b)(6) 2020, the patient had a left total knee arthroplasty to address end-stage degenerative joint disease of the left total knee.Depuy components including a depuy patella and depuy cement x2, were implanted during this procedure.On (b)(6) 2021, the patient had a revision left total knee arthroplasty to address left knee aseptic loosening femoral and tibial component, massive bone loss, pain, dysfunction, and instability.During the procedure the surgeon observed, osteolysis ¿ type material, the femoral and tibial tray were both grossly loose, where the cement had debonded from implant/cement interface and the cement/bone interface.The patella was not revised.Competitor components were implanted during this procedure, including competitor cement 3.Doi:(b)(6) 2020.Dor: (b)(6) 2021.(left knee).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

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.

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.

Event Description

Medical records received indicated that "patient received a depuy attune rp posterior stabilized left total knee replacement on (b)(6) 2020, and utilizing depuy bone cement, to address pain and end-stage degenerative joint disease.There were no complications identified.On (b)(6) 2021, patient's left knee was revised to address, pain, knee dysfunction, aseptic loosening of the femur and tibial tray components at the cement to implant interfaces, massive femoral and tibial bone loss, and joint instability.There was evidence of significant tibial and femoral osteolysis.The patella was retained, but femur, tibial tray, and tibial insert products were revised.".

• Brand Name: ATTUNE PS FEM LT SZ 8 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: 13657168
• MDR Text Key: 289224757
• Report Number: 1818910-2022-03954
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295041658
• UDI-Public: 10603295041658
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-10-108
• Device Catalogue Number: 150410108
• Device Lot Number: C70007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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 35MM.; ATTUNE PS FEM LT SZ 8 CEM.; ATTUNE PS RP INSRT SZ8 5MM.; ATTUNE RP TIB BASE SZ 8 CEM.; DEPUY1 GENTAMICIN CEMENT 40G.; DEPUY1 GENTAMICIN CEMENT 40G.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male