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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Limb Fracture (4518); Insufficient Information (4580)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: lin b, lan y, lu z, xie s, lin f, weng y, feng e, chen j.The compared study about femoral stem malalignment with or without the special curved rasp during daa total hip arthroplasty.Bmc musculoskelet disord.2023 apr 22;24(1):319.Doi: 10.1186/s12891-023-06409-7.Pmid: 37087443; pmcid: pmc10122324.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: lin b, lan y, lu z, xie s, lin f, weng y, feng e, chen j.The compared study about femoral stem malalignment with or without the special curved rasp during daa total hip arthroplasty.Bmc musculoskelet disord.2023 apr 22;24(1):319.Doi: 10.1186/s12891-023-06409-7.Pmid: 37087443; pmcid: pmc10122324.Objective and methods: authors investigated whether the application of a canal opening curved rasp on the femoral side is effective in reducing the incidence of stem malalignment in total hip replacement with direct anterior approach (daa-tha), followed by the analysis of the independent risk factors affecting stem malalignment.A retrospective analysis was carried out covering 160 patients undergoing daa-tha from january 2019 to december 2021, with depuy tri-lock bps femoral stem implanted in all 113 patients, according to inclusion and exclusion criteria.Patient gender, age, body mass index, preoperative diagnoses, dorr classification, far ratio (vertical height of greater troch divided by the horizontal length of the femur at the proximal tip of the lesser troch), pelvic morphology ratio, and survey scores were analyzed to explore factors influencing the malalignment of the femoral prosthesis implantation.Then data of patients were divided into group a (use of rasp) and group b (no rasp) according to whether the curved rasp was utilized during the operation.Analysis was performed to compare the incidence of femoral stem malalignment between the two groups.Authors did not provide any information with respect to manufacturer or product specifics in relation to the acetabular side constructs implanted with the tri-lock bps stems.The authors also did not provide specific patient information by case number or age/gender, nor did they identify specific product code/lot code details with regards to implanted devices.Results: two independent risk factors, patient bmi, and far ratio, each affected femoral stem malalignment.The increased bmi was associated with a higher probability of femoral stem malalignment.Additionally, far ratio < 1 was 1.15 times higher to have femoral stem malposition than that a far ratio >1.Further grouping analysis showed that the incidence of femoral stem malalignment in patients with intraoperative application of curved rasp was 27%, while for those patients without curved rasp use, the incidence of femoral stem malalignment increased significantly to 48.7%.The placement angle of prosthesis in group a was significantly better than that in group b, especially mild femoral stem malalignment (0%) and severe femoral stem malalignment (2.70%), and the difference was statistically significant.There found no significant difference in age, gander, intraoperative complications and last follow-up assessment of womac survey scores between the two groups of patients.Conclusions: in daa-tha, bmi and far ratio act as the independent risk factors for femoral stem malalignment.Intraoperative use of a curved rasp significantly reduces the incidence of malalignment of the femoral stem.Complications: (no treatments specified) group a (rasp use) malposition stem (inversion): 10 malposition stem (implantation angle > 3 degrees): 9 intraoperative femur perforation or fracture: 37 group b (no rasp) malposition stem (inversion): 37 malposition stem (implantation angle > 3 degrees): 37 intraoperative femur perforation or fracture: 74.

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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18935574
• MDR Text Key: 338107490
• Report Number: 1818910-2024-06110
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/11/2024
• 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