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 Wound Dehiscence (1154); Pulmonary Embolism (1498); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Urinary Retention (2119); Thrombosis/Thrombus (4440); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)

Event Type  Injury  

Event Description

Article entitled "a randomized trial investigating the cost-utility of patient-specific instrumentation in total knee arthroplasty in an obese population" written by bryn o.Zomar, phd, edward m.Vasarhelyi, md, msc, frcsc, lyndsay e.Somerville, phd, brent a.Lanting, md, msc, frcsc, james l.Howard, md, msc, frcsc, and jacquelyn d.Marsh, phd published by the journal of arthroplasty on april 30, 2021 was reviewed.The purpose of our study was to determine, using a prospective, randomized controlled trial, the cost-utility of psi compared with standard instrumentation for tka in an obese patient population from both public health care payer and societal perspectives.All patients were implanted with attune total knee implants (cement manufacturer is unknown).All patients had surgery between january 2015 and january 2018.All patients were followed up for 12 months.173 patients were involved within the study.87 were soc (standard of care) and 86 were psi (patient-specific instrumentation) adverse event involving depuy ¿ synthes products: adverse events were broken down into intra-op, during hospitalization, postoperatively, medical complications, and other surgeries.The adverse events within the medical complications and other surgeries will not be included as an adverse event related to the study participation as the author draws attention to one of the medical complications that it was unrelated to the study participation.The remaining medical complications and other surgeries noted appear to be comorbidities of the study patients.Soc adverse events: partial mcl injury (1) during surgery and was surgical repaired with an allograft and augment.Treated with brace post op.Urinary retention (5) no treatment noted.Hypotension (2) no treatment noted.Pulmonary embolism (1) bilateral pes and were treated with blood thinner medication for 90 days.Drug reaction (2) no treatment noted.Deep infection (2) treated with i&d¿s and antibiotics.Superficial infection (7) no treatment noted.Wound dehiscence (1) no treatment noted.Stiffness (1) no treatment noted.Psi adverse events: urinary retention (3) no treatment noted.Hypotension (1) no treatment noted.Drug reaction (2) no treatment noted.Deep vein thrombosis (1) treated with iv blood thinners.Deep infection (1) treated with oral antibiotics.Patient declined additional treatment and infection did not resolve.Superficial infection (1) no treatment noted.Wound dehiscence (3) no treatment noted.Stiffness (1) no treatment noted.Laxity (1) no treatment noted.Increased pain (4) no treatment noted.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12672790
• MDR Text Key: 282554467
• Report Number: 1818910-2021-23128
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• 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
• Patient Outcome(s): Required Intervention