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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Synovitis (2094); Unspecified Tissue Injury (4559)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewedmarconi d, vigorita v, bryk e.Histological findings in six failed metal-on-metal implants.J long term eff med implants.2017;27(1):85-96.Doi: 10.1615/jlongtermeffmedimplants.2018020685.Pmid: 29604953.Objective and methods: adverse reaction to metal debris (armd) and alval are major causes of implant failure leading to revision surgery in patients with metal-on-metal (mom) hip arthroplasties.However, the pathogenesis and its association to implant wear are poorly understood and previous studies have yielded discrepant results.The purpose of this article was to retrospectively review six cases of patients who underwent mom hip arthroplasties and required early revision.Tissue removed at revision surgery was analyzed histologically by two independent reviewers.All six patients (four males, two females) underwent revision hip arthroplasty after early failure.Revision occurred between 18 and 56 months after the index procedure.Four patients received asr-xl mom implants from depuy, the other two were competitor constructs.This complaint will capture the 4 asr-xl revisions.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: asr xl (femoral, sleeve, cup, stem) adverse event(s) and provided interventions associated with depuy devices: case 1: 60-year-old female patient.Case 2: 60-year-old male patient.Case 3: 61-year-old female patient.Case 5: 56-year-old male patient.All patients were revised for the same reason and all patients had the same histological and device findings: evidence of metal wear and corrosion on all 4 devices.Pain, synovitis, metallosis, erosion of the tissues around the devices, soft tissue necrosis, scar formation, inflammation, and soft tissue injury to the surrounding tendons, ligaments, and musculature.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot; a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17300255
• MDR Text Key: 319045128
• Report Number: 1818910-2023-13939
• 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,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• 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?: Yes
• Date Manufacturer Received: 07/13/2023
• 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
• Treatment: UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNK HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female