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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 02/09/2022

Event Type  Injury  

Event Description

Article entitled ¿reliability of slice-encoding for metal artefact correction (semac) mri to identify prosthesis loosening in patients with painful total hip arthroplasty ¿ a single centre, prospective, surgical validation study¿ written by tsuneari takahashi, md, phd, siddharth thaker, mbbs, md, frcr, giovanni lettieri, md, phd, anthony redmond, phd, msc, ffpm rcps, fcpodm, michael r.Backhouse, phd, bsc (hons), fcpodm, ffpm, rcps (glasg), martin stone, frcs (t and o), m phil (leeds), hemant pandit, frcs (t and o), d phil (oxon) and philip o'connor, mbbs, mrcp, frcr, ffsem (uk) published in the british institute of radiology on february 9, 2022 was reviewed.The goal of the study was to validate reliability of slice-encoding for metal artefact correction (semac)-mri findings in prosthesis loosening detection by comparing them to surgical outcomes (gold standard) in symptomatic patients following hip arthroplasties.To evaluate periprosthetic anatomical structures in symptomatic patients to identify an alternative cause of hip symptoms.55 hips (47 patients) were included within the study.All were implanted with marathon acetabular cup and corail cementless stem.Cement manufacturer for the marathon cup wasn¿t mentioned.Adverse events ¿ 25 hips reported pain.Managed conservatively among which pain had recovered in 21 hips on follow-up.8 hips had trochanteric bursitis treated with steroid injections.11 patients reported pain and underwent revision surgery for aseptic loosening of the acetabular cup or femoral stem.(unknown interface).

Manufacturer Narrative

Product complaint # (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.

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 CUP
• Type of Device: HIP ACETABULAR CUP
• 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: 18182099
• MDR Text Key: 328671513
• Report Number: 1818910-2023-23792
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2023
• 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