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

Catalog Number UNK HIP FEMORAL STEM SOLUTION

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646); Limb Fracture (4518); Insufficient Information (4580)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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: dagneaux l, sculco pk, haight hj, larson dr, howard jl, abdel mp, berry dj.Extensively porous-coated stems demonstrate excellent long-term survivorship in revision total hip arthroplasty.J arthroplasty.2023 jul;38(7s):s217-s222.Doi: 10.1016/j.Arth.2023.03.004.Epub 2023 mar 10.Pmid: 36907385; pmcid: pmc10326832.Objective and methods: the authors¿ study aimed to evaluate long-term outcomes of a large patient population who received the same extensively porous-coated depuy solution femoral stems for total hip arthroplasty revision treatment.Patients were collected from their institutional total joint registry, for revisions surgeries occurring between 1992 thru 2003.No other product information was provided for any patients except that they all received solution stems during their revision surgeries.Acetabular component models/manufacturers were not identified by the authors.Results: overall, from 925 solution stems in 880 patients, there were 161 component revisions.The femoral stem was removed or re-revised in 53 cases.Aseptic loosening of the stem occurred in 26 patients.Among the 26 stems re-revised for aseptic loosening, there were 6 intraoperative femur fractures that occurred.Overall, intraoperative fracture occurred in 142 cases.There were 16 cases of periprosthetic joint infection (pji) requiring stem removal, 11 femoral stem fractures (all stem fractures occurred in the proximal 1/3 of the femoral stem at metaphyseal-diaphyseal junction), 5 periprosthetic femur fractures requiring stem revision, and 3 cases of hip dislocation.There were 59 acetabular revisions with the femoral stem left in situ, with the most common reason for acetabular revision being aseptic loosening in 42 hips.Other reasons for acetabular revision included dislocation in 7 cases and metallosis in 2 cases.There were 55 isolated insert re-revisions, including 23 for polyethylene wear, 23 for dislocation-related complications, 8 for debridement with retention of components to treat pji, and 1 instance of insert re-revision occurring during a debridement to treat heterotopic ossification.Re-operations with no component re-revision occurred in 23 hips, including 16 periprosthetic fractures treated with open reduction and internal fixation with stem retention, and 7 removals of painful hardware (no details provided).Conclusion: in this large series of revision thas using a single extensively porous-coated stem design, the cumulative incidence of re-revision for aseptic femoral loosening was just 3% at 20 years.The data confirms the durability of this stem in femoral revision, providing a long-term benchmark for comparison when using newer uncemented revision stems.

• Brand Name: UNK HIP FEMORAL STEM SOLUTION
• 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 46581-0988 ; 3035526892
• MDR Report Key: 18475814
• MDR Text Key: 332444361
• Report Number: 1818910-2024-00606
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2024

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 SOLUTION
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/09/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention