MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK

Catalog Number UNK HIP FEMORAL STEM TRI-LOCK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Limb Fracture (4518)

Event Date 06/05/2023

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: zhang b, li w, li m, ding x, huo j, wu t, han y.The role of 3-dimensional preoperative planning for primary total hip arthroplasty based on artificial intelligence technology to different surgeons: a retrospective cohort study.Medicine (baltimore).2023 jun 23;102(25):e34113.Doi: 10.1097/md.0000000000034113.Pmid: (b)(4); pmcid: (b)(4).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: zhang b, li w, li m, ding x, huo j, wu t, han y.The role of 3-dimensional preoperative planning for primary total hip arthroplasty based on artificial intelligence technology to different surgeons: a retrospective cohort study.Medicine (baltimore).2023 jun 23;102(25):e34113.Doi: 10.1097/md.0000000000034113.Pmid: (b)(4); pmcid: (b)(4).Objective and methods: authors studied the impact of preoperative planning with computed tomography (ct)-based 3-dimensional (3d) templating software for precise placement of total hip arthroplasty (tha) components.They investigated the role of a software providing 3-dimensional preoperative planning for primary total hip arthroplasty based on artificial intelligence technology¿artificial intelligence hip (aihip)¿and its impact for surgeons with different experience levels in primary tha.In this retrospective cohort study, patients who had undergone tha with the help of the aihip, were matched to patients who had undergone tha without the help of the aihip, by age and the doctor who operated on them.The subjects were divided into 4 groups, senior surgeon (chief of surgery) with aihip group, senior surgeon without aihip group, junior surgeon (associate chief of surgery) with aihip group and junior surgeon without aihip group.The general data, imaging index, clinical outcomes and accuracy of stem size prediction and cup size prediction were retrospectively documented for all patients.A pinnacle acetabular cup and tri-lock femoral stem were implanted in all cases, with ceramic heads on polyethylene liners.The authors 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: there was a significant difference in discrepancy in leg length, neck-shaft angle, and femoral offset between the healthy side and the affected side, operation duration, decrease in hemoglobin (hb) per 24 hours, intraoperative radiation exposure frequency and postoperative complications among the patients in junior surgeon group.No significant differences were found between senior surgeon groups.The stem sizes of 95% were accurately estimated to be within 1 stem size, and 97% of the cup size estimates were accurate to within 1 cup size in senior surgeon group with aihip.A total of 87% stem sizes were accurately estimated to be within 1 stem size, and 85% cup sizes were accurate to within 1 cup size in junior surgeon group with aihip.In conclusion, our study suggests that an ai-based preoperative 3d planning system for tha is a valuable adjunctive tool for junior doctor and should routinely be performed preoperatively.Complications: senior surgeon without aihip, senior surgeon with aihip.Periprosthetic fracture: 22.Hip dislocation: 21.Aseptic loosening: 00.Thigh pain: 42.Complications: junior surgeon without aihip, junior surgeon with aihip.Periprosthetic fracture: 82.Hip dislocation: 23.Aseptic loosening: 60.Thigh pain: 45.

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: UNK HIP FEMORAL STEM TRI-LOCK
• Type of Device: 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: 18938261
• MDR Text Key: 338070260
• Report Number: 1818910-2024-06111
• 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 Health Care Professional
• 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 TRI-LOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/07/2024
• Supplement Dates FDA Received: 04/09/2024
• 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