MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SROM

Catalog Number UNK HIP FEMORAL STEM SROM

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

Patient Problem Physical Asymmetry (4573)

Event Date 03/06/2020

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

Literature article entitled, "leg length balance in total hip arthroplasty for patients with unilateral crowe type iv developmental dysplasia of the hip", by yin-qiao du, et al, published by orthopaedic surgery, volume 12, number 3, june, 2020, was reviewed.The study reported on 60 patients diagnosed with unilateral crowe type iv developmental dysplasia of the hip (ddh).All 60 were treated with total hip arthroplasty (tha), using depuy pinnacle cups, ceramic liners and heads, and s-rom stems using proximal sleeves or cones.Of these, 48 patients presented without pre-existing leg length discrepancy (lld) prior to the tha, defined by the authors as lld < 10 mm.Within these 48 patients, 26 received additional shortening subtrochanteric osteotomies as part of their surgical treatment.The study sought to explore the issue of leg length balance in total hip arthroplasty when considering treatment with and without shortening subtrochanteric osteotomy (ssto), evaluated through by way of full-length anteroposterior radiographs.The results demonstrated that the use of ssto led to femoral shortening on the operated side.Therefore, it is recommended, when utilizing the authors¿ technique, that positioning of the s-rom proximal sleeve or cone is essential in controlling the incidence of lld, dependent on whether ssto was performed or not.Based upon article figure 3, two hips exhibited lld of approximately 20 mm.The remaining 58 hips were reported to be 19 mm or less of lld, whether shorter or longer than the non-operative leg.The study indicated no other complications, including revision surgeries.No specific patient identifier, age, or gender details were provided.No product or lot code information was provided.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached images could not confirm the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK HIP FEMORAL STEM SROM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11192963
• MDR Text Key: 227774199
• Report Number: 1818910-2021-01383
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM SROM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention