MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH; BROACHES

Catalog Number UNK BROACH

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

Patient Problem Limb Fracture (4518)

Event Date 02/27/2022

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

Article entitled "femoral perforation during direct anterior approach total hip arthroplasty: incidence, cohort characteristics and management" written matthew c.Kinney, md, henry ho, ms, and william g.Hamilton, md published by the journal of arthroplasty on february 27, 2022, was reviewed.The aim of this study is to present a series of intra-operative femoral perforations to help determine an incidence for this complication, report on the peri-operative management and outcomes, and identify cohort characteristics associated with perforation.3973 primary and conversion tha cases were performed by a single surgeon during direct anterior approach from 2009 to 2021.The surgeon used trilock, corail, and actis stems.Among those 3973 cases, there were 16 cases with an intra-operative femoral perforation.Based off the literature article is appears the fractured occurred during broaching.Adverse events: case #1 ((b)(6) male) ¿ intra-operative femoral perforation (right hip) in 2010.Perforation was treated with a longer stem and cerclage wires to prevent fracture propagation.Patient was also put on 10% weight bearing.Case #2 ((b)(6) female) - intra-operative femoral perforation (left hip) in 2011.No intra-operative treatment and patient was treated with 50% weight bearing.Case #3 ((b)(6) female) - intra-operative femoral perforation (right hip) in 2011.No intra-operative treatment and patient was treated with 50% weight bearing.Patient did sustain a post-operative dvt.Case #4 ((b)(6) male) ¿ intra-operative femoral perforation (right hip) in 2011.Perforation was treated with a longer stem and 50% weight bearing.Case #5 ((b)(6) female) - intra-operative femoral perforation (left hip) in 2013.No intra-operative treatment and patient was treated with 50% weight bearing.Case #6 ((b)(6) male) - intra-operative femoral perforation (right hip) in 2014.No intra-operative treatment and patient was treated with 50% weight bearing.Case #7 ((b)(6) male) - intra-operative femoral perforation (left hip) in 2014.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #8 ((b)(6) female) - intra-operative femoral perforation (right) in 2016.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #9 ((b)(6) male) - intra-operative femoral perforation (left) in 2016.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #10 ((b)(6) male) - intra-operative femoral perforation (right) in 2017.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #11 ((b)(6) male) - intra-operative femoral perforation (right) in 2017.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #12 ((b)(6) female) - intra-operative femoral perforation (left) in 2017.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #13 ((b)(6) female) - intra-operative femoral perforation (left) in 2018.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #14 ((b)(6) female) - intra-operative femoral perforation (right) in 2020.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #15 ((b)(6) male) - intra-operative femoral perforation (right) in 2020.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.Case #16 ((b)(6) female) - intra-operative femoral perforation (right) in 2020.No intra-operative treatment and patient was treated with weight bearing as tolerated with a walker.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All images in the literature article were reviewed and no failures were identified.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 finish goods lot number or product code was provided for this device.

• Brand Name: UNK BROACH
• Type of Device: BROACHES
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14073314
• MDR Text Key: 288984471
• Report Number: 1818910-2022-06462
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention