• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number UNK_SHC
Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 01/08/2017
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding loosening involving an unknown accolade tmzf stem was reported. A review of the provided x-rays by a clinical consultant confirmed loosening and osteolyis. The review suggested a possible infection but could not confirm this with current available information. Method & results: -device evaluation and results:not performed as no items were returned. -medical records received and evaluation: a review of the provided medical x-rays by a clinical consultant indicated: [. ] the stem has adequate size and position but there is severe osteolysis around the entire stem. Stability appears to be maintained only by the stem tip section of the device as evident by the local cortical bone hypertrophy. The cup has adequate size and inclination although anteversion is rather low as evident by the almost straight line projection of the cup opening circle. Also around the entire cup is advanced osteolysis evident although also the cup appears still more or less stable in the bone. [. ] the cup has turned loose with extreme migration and tilting. [. ] [. ] given the timeframe of 7-years before failure, it appears that such an infection must have been of hematogenous origins from an infected focus somewhere else in the body with metastatic transport of bacteria to the arthroplasty. Primary deep joint infections in arthroplasties usually become manifest within 2-years, any later infections have their origins outside the arthroplasty. There is no clinical information to support any of these assumptions but the radiological picture is very suggestive. [. ] -device history review could not be performed as the device lot is unknown. -complaint history review could not be performed as the device lot is unknown. Conclusions: a review by a clinical consultant noted: [. ] given the limited facts and findings, this case cannot be solved with adequate certainty although low-grade infection as root cause for failure remains the most likely option until proven otherwise. This would represent a procedure-related failure mode without device related aspects although the level of evidence remains very thin and more information is required to solve this case with more certainty. The exact cause of the event could not be determined because insufficient information was provided. Further information such as device details, return of device, pathology reports, operative reports, patient history & follow-up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened. Product surveillance will continue to monitor for trends.
Event Description
Cup loosened, visible osteolysis on xray. Pain associated with grossly loose cup.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceHIP IMPLANT
Manufacturer (Section D)
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
ida industrial estate
carrigtwohill NA
Manufacturer Contact
sarah smelko
325 corporate drive
mahwah, NJ 07430
MDR Report Key6457006
MDR Text Key71683549
Report Number0002249697-2017-01112
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2017
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 Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1