MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

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

Patient Problems Inflammation (1932); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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: peeters w, vandeputte fj, timmermans a, roose s, verhaegen jc, corten k.Can patients who have low-grade hip osteoarthritis expect the same outcome after total hip arthroplasty compared to those who have end-stage osteoarthritis? - a matched case-control study.J arthroplasty.2024 feb 16:s0883-5403(24)00111-6.Doi: 10.1016/j.Arth.2024.02.012.Epub ahead of print.Pmid:(b)(4).Objective and methods: authors sought to understand whether patients who presented with low-grade osteoarthritis and received anterior approach total hip arthroplasties showed benefits comparable to those patients who presented with end-stage osteoarthritis and received like treatment.A retrospective study of patients from a multi-surgeon, single high-volume center, utilizing prospectively recorded data was gathered for surgeries between january 1st, 2017, and december 31st, 2019.Only patients who had a minimum follow-up of 2 years were included in the analysis.Of the total of 2,189 primary thas that were performed on 1,879 patients, 33 were excluded for consideration due to ¿death unrelated to the hip condition during follow-up¿.After addressing other exclusion criteria, authors ultimately matched 60 patients with low-grade osteoarthritis 1:1, by age, sex, and bmi, to 60 patients with end-stage osteoarthritis.Authors noted that depuy pinnacle cups and liners were implanted in 109 patients, while 11 competitor cups and liners were implanted in the rest.Likewise, depuy corail femoral stems and heads were implanted in 109 patients, with 11 competitor stems and heads being implanted in the rest.The medical histories of these 120 cases were examined in detail, and cases with pertinent medical histories that might impact the outcomes of tha were also excluded, leaving 50 cases each in low-grade and end-stage groups for final inclusion.The authors did not break out specific patients by case numbers of age/gender demographics, nor did they provide product/lot code manufacturer information for implants placed.Results: authors concluded that patients who have low-grade oa can expect substantial clinical improvement after tha.However, the improvement is lower compared to patients who have end-stage oa.Complications: patient experienced hip dislocation (1 low-grade oa case versus 0 end-stage cases), no treatment details provided by the authors.Peri-articular muscle envelope complaints were significantly more common in the low-grade oa group, compared to the end-stage oa group, with 9 cases versus 1 case respectively.Both psoas tendinopathy (4 versus 0 cases) and greater trochanter pain (6 versus 1 cases) occurred more often in the low-grade oa group versus the end-stage oa group.Postoperative low back pain symptoms were also more common in the low-grade oa group compared to the end-stage group (7 versus 2 cases).Finally, 2 patients experienced lateral femoral cutaneous nerve (lfcn) injury in the low-grade oa group versus 0 patients in the end-stage oa group.

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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18861953
• MDR Text Key: 337182939
• Report Number: 1818910-2024-05397
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention