MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Hemorrhage/Bleeding (1888); Physical Asymmetry (4573)

Event Date 07/03/2021

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

"literature article reviewed.Fansur m, yurdi na, stoewe r.The intraoperative use of a calliper predicts leg length and offset after total hip arthroplasty.Component subsidence influences the leg length.J orthop surg res.03 jul 2021.Pmid: 34217347.The article's purpose was to evaluate intraoperative use of a calliper predicts leg length and offset after total hip arthroplasty.Patient data: the mean age of the patients was 51 years (17¿74), with 30 out of 54 patients being male.Depuy products: tha was noted to be a depuy construct, specific product line was not provided.The noted caliper used intra-operatively was competitor.Adverse events (n) = quantity not addressed within the article.(5) intraoperative proximal femoral calcar fracture - treated by a cerclage.(2) more than 3° varus/valgus malalignment of the femoral stem ¿ treatment not noted (1) undisplaced pelvic fracture intraoperatively - treated conservatively without further consequences (1) directly postoperatively liner disassociation from the cup ¿ revision (1) undersized acetabular cup ¿ revision (6) major intra-operative blood less ¿ blood transfusion postoperatively (n) leg length discrepancy ¿ treatment not noted.".

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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: 15486048
• MDR Text Key: 300583526
• Report Number: 1818910-2022-18738
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• 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: 09/26/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 10/30/2022
• 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