MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-035

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

Patient Problems Fatigue (1849); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Litigation complaint received ad (b)(6) 2022.Litigation document reported that the plaintiff alleges bursitis, pain, sometimes felt unstable, suffering, unable to walk from the parking lot to the door and functional limitation.It was also reported that the patient was revised due to severe tibial loosening.Doi: (b)(6) 2016.Dor: 2021.Right knee.The patient has depuy bilateral knee implants and bilateral revision as well.

Event Description

Patient had bilateral total knee revision to address bilateral aseptic loosening of the tibial tray.Prior to surgery medical records note the patient reports having pain, weakness, deficiency of quad strength, and bursitis in bilateral knees.The patella was not revised.The tibial trays were loose at the cement/implant interface.The femoral components and inserts were removed with no allegation of deficiency noted.Competitor components were implanted during this procedure, including competitor cement.

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: added: a2 (birth date), b5, b7, d4 (procode,lot,exp,udi), g4 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, a2 (age), b3, d1, d2, d2b, d6b, d10 and g1.

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: added: h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (impact code).

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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14786524
• MDR Text Key: 295026212
• Report Number: 1818910-2022-11535
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295056683
• UDI-Public: 10603295056683
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 1518-20-035
• Device Catalogue Number: 151820035
• Device Lot Number: 8244684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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 35 MM MEDIALIZED DOME PATELLA; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ5 5MM; ATTUNE RP TIB BASE SZ 4 CEM; ATTUNE SIZE 4 ROTATING PLATFORM TIBIAL BASE PLATE; ATTUNE SIZE 5 X 5 MM RP/PS POLYETHYLENE; DEPUY ATTUNE SIZE 5 NARROW RIGHT FEMUR; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 73 KG