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 Problem Physical Asymmetry (4573)

Event Date 09/05/2019

Event Type  malfunction  

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 ¿a simple method to minimize leg length discrepancy in hip hemiarthroplasty" written by guodong wang, ai guo, fei yu, bo yang, haomiao yu, naicheng diao, lifeng ma, hua qiang, erhong zhao, published by clinical interventions in aging, september 5, 2019 was reviewed.The purpose of this study is to evaluate the accuracy of the ¿simple method¿ to minimize leg length discrepancy during hip arthroplasty.A total of 47 patients who suffered from unilateral femoral neck fracture and underwent hip hemiarthroplasty between 2015 and 2018 were enrolled in this study.We measured the diameter of the contralateral femoral head (d) and the distance (l) between the center of the femoral head and the top of lesser trochanter in the antero-posterior pelvic x-ray view before the operation, the ratio (r) of d to l was calculated.During the operation, the diameter of the femoral head (d) was measured using a vernier caliper.Then, the distance should be obtained from the center of the femoral head prosthesis to the lesser trochanter was calculated according to the contralateral ratio r.Results: the mean lld was 4.4±3.2 mm (-4.0 to 11.1 mm), 80.9% of the patients had leg length discrepancy.A total of 47 patient¿s were involved in this study and underwent hip hemiarthroplasty with tri-lock stem, corail collarless standard offset/high offset stem, bipolar femoral head.The only adverse event noted during this study was leg length discrepancy.There were no interventions, revisions, or other allegations of deficiency.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device was received for examination.No lot code provided.All available images were reviewed and no evidence of implant fracture, disassociation or anything indicative of a device non-conformance was found.Allegation could not be confirmed, root cause could not be established.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 : no evidence or deficiency suspecting an error in manufacturing/material that would be a contributing factor in the reported allegation(s) was identified.A manufacturing records evaluation (mre) was not necessary (nor possible without the lot code).

• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12641092
• MDR Text Key: 276687946
• Report Number: 1818910-2021-22823
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/06/2021

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: 10/05/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/03/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention