MAUDE Adverse Event Report: DEPUY IRELAND 9616671 UNK ATTUNE FEMORAL

Catalog Number UNK ATTUNE FEMORAL

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

Patient Problems Fall (1848); Pain (1994); Unspecified Musculoskeletal problem (4535)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this patient had a right total knee that was painful.The patient was noncompliant and had multiple falls.The patient had blown out her mcl and patella tendon.When the surgeon opened the knee up, it was discovered that the tibial insert has spun 180deg backwards and the patient had been walking with the knee insert in this position.The components are well fixed, so the surgeon did an insert exchange.There is no surgical delay.Doi: (b)(6) 2019; dor: (b)(6) 2022; affected side: right knee.

Manufacturer Narrative

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

Event Description

It was reported that this patient had a right total knee that was painful.The patient was noncompliant and had multiple falls.The patient had blown out her mcl and patella tendon.When the surgeon opened the knee up, it was discovered that the tibial insert has spun 180deg backwards and the patient had been walking with the knee insert in this position.The components are well fixed, so the surgeon did an insert exchange.There is no surgical delay.Doi: (b)(6) 2019; dor: (b)(6) 2022; affected side: right knee.

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.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: ATTUNE 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: 13576595
• MDR Text Key: 285930772
• Report Number: 1818910-2022-03250
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE FEMORAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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: ATTUNE PS RP INSRT SZ 4 12MM.; UNK ATTUNE FEMORAL.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female