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

Catalog Number UNK_SHC

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)

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

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's left hip was revised due to disassociation of the head from the stem.Intraoperatively, trunnionosis, corrosion, "a lot of black tissue", and liner wear at the rim were noted.A 36 +10 lfit v40 head, accolade tmzf stem, and poly liner were revised to an eon stem, ceramic femoral head, and mdm/adm liner construct.

Event Description

It was reported that the patient's left hip was revised due to disassociation of the head from the stem.Intraoperatively, trunnionosis, corrosion, "a lot of black tissue", and liner wear at the rim were noted.A 36 +10 lfit v40 head, accolade tmzf stem, and poly liner were revised to an eon stem, ceramic femoral head, and mdm/adm liner construct.

Manufacturer Narrative

An event regarding disassociation involving an accolade stem was reported.The event was confirmed by inspection of the received image of the device.Method & results: device evaluation and results: the device was not received.Visual inspection of the provided image of the device noted stem neck wear, consistent with taper lock failure which leads to disassociation of the head from the stem.The stem is covered with blood stains.Dimensional, functional, material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: not performed as the device was not identified properly.Complaint history review: not performed as the device was not identified properly.Conclusions: it was reported that the patient's left hip was revised due to disassociation of the head from the stem.Intraoperatively, trunnionosis, corrosion, "a lot of black tissue", and liner wear at the rim were noted.Visual inspection of the provided image of the device noted stem neck wear, consistent with taper lock failure which leads to disassociation of the head from the stem.The stem is covered with blood stains.The exact cause could not be determined as insufficient information was available.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN ACCOLADE TMZF HIP STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8526903
• MDR Text Key: 142340606
• Report Number: 0002249697-2019-01661
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention