MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ATTUNE KNEE TIBIAL INSERT

Catalog Number UNK ATTUNE KNEE TIBIAL INSERT

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Joint Laxity (4526); Joint Contracture (4528); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi # is unavailable.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

Third revision was done due to unknown allegation.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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

Additional information received: a.Please confirm the reason for 3rd revision surgery? instability.B.Was there any suggestion by anyone indicating that there was or maybe a deficiency with the product(s)? if yes, please provide details.No.They does not believe there was a device deficiency.C.Was there a surgical delay because of this event? if yes, what is the duration of the delay? no delay.D.Radiographs/x-ray films: please provide all x-rays relevant to the reported event for example - pre-operative, post-primary, pre-revision, and intervening time points.This patient is in the attune revision study, patient id (b)(6).They have pre-op (baseline x-ray), 6 weeks post-op, 1 year post-op, and 2 years post-op for this patient.Operation note received: 2015: medical records state the patient underwent a primary tka (manufacturer unknown).2017: right revision was performed (manufacturer and reason unknown) (b)(6) 2019: additional revision was performed for instability where competitor components were removed and attune revision size 8 femur, 50x14mm cemented stem, distal augments 4mm medial and lateral, posterior augments 8mm medial and lateral, attune revision rp size 7, 7mm ps polyethylene, 5mm medial and lateral augments, 30x14 cemented stem and a 41 medialised patella was implanted.Competitor cement was used.(b)(6) 2022: clinic notes state the patient is becoming more ¿lax¿ and has swelling and pain.He also has difficulty walking requiring a walking stick for support.Pmh includes diabetes with neuropathy in both feet.The patient has knee stiffness with a 10 degree flexion deformity.(b)(6) 2022: a poly exchange was performed due to instability.Minimal effusion was seen.Scar was removed from the extensor mechanism.Mild wear noted on the anterolateral aspect of the poly.Washout was performed.A full release was performed in order to fix the flexion deformity.

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Type of Device: ATTUNE 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15826563
• MDR Text Key: 303934366
• Report Number: 1818910-2022-23270
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2022

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 ATTUNE KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 12/01/2022; 12/16/2022
• Supplement Dates FDA Received: 11/30/2022; 12/15/2022; 12/19/2022
• 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: COMPETITOR CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 78 KG