MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF STEM; HIP IMPLANT

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.

• Brand Name: UNKNOWN ACCOLADE TMZF STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6457006
• MDR Text Key: 71683549
• Report Number: 0002249697-2017-01112
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• 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 Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention