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

Catalog Number UNK_SHC

Device Problem Degraded (1153)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Injury (2348); Reaction (2414)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation of a unknown accolade stem and v40 metal head taper lock with wear on the trunnion of the stem as reported.The disassociation event was not confirmed however wear of the trunnion of the stem was confirmed through images of the explanted devices method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs provided are of the recently explanted stem and head.There is tissue/blood around the body of the stem.The trunnion of the stem is worn.From the photographs there appears to be a black mark/substance on the rim of the head.There also appears to be blackening inside the head.Medical records received and evaluation: not performed as no information was provided for review.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the explant photographs taken during revision surgery confirm trunnion wear, however, the disassociation event could not be confirmed and the exact cause of the wear event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, histopathology reports, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.

Event Description

It was reported that patient's right hip was revised due to pain, swelling and disassociation of the head from the stem.Intraoperatively, black tissue was noted in the wound, and the trunnion was observed to be worn.Ion levels were not reported.A 36 +10 lfit v40 head, accolade tmzf stem, and a trident 0° 36mm liner were revised to a competitor stem and head with a stryker liner.The psl shell was not revised.

• Brand Name: ACCOLADE TMZF STEM
• Type of Device: UNKNOWN HIP PRODUCT
• 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: anna smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8184665
• MDR Text Key: 131018439
• Report Number: 0002249697-2018-04095
• Device Sequence Number: 1
• Product Code: JDG
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2018

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_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/20/2018
• 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
• Patient Age: 70 YR