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

Catalog Number UNK_JR

Device Problems Degraded (1153); Material Discolored (1170)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)

Event Date 12/22/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding revision due to pain and metallosis involving an unknown stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the product was not returned for evaluation.Clinician review: not performed as medical records were not provided.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device identification and evaluation, operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that the patient's right hip was revised due to pain and metallosis.Intraoperatively, trunnionosis and "disoloration" of the liner were observed.A stryker shell, head, and liner were revised to a stryker ceramic head, shell, and liner.Update january 8, 2019: as per clinical consultant, "the 'discoloration' as noted in the photo is normal from extended exposure to synovial fluid and does not represent either pathology or faulty manufacturing or material factors.".

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8258076
• MDR Text Key: 133395379
• Report Number: 0002249697-2019-00224
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2018
• Initial Date FDA Received: 01/17/2019
• 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): Hospitalization; Required Intervention