MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 54MM; IMPLANT

Catalog Number 502-01-54E

Device Problems Device Slipped (1584); Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 03/30/2015

Event Type  Injury  

Event Description

The patient presented in the er on (b)(6) 2015 due to the head separating from the stem.The surgeon found that the trunnion had been worn considerably.There was black debris found throughout the entire hip area.Upon removing the poly from the cup, the cup had also dislodged from the bone.All implants had to be removed.New devices were then implanted successfully.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The patient presented in the er on (b)(6) 2015 due to the head separating from the stem.The surgeon found that the trunnion had been worn considerably.There was black debris found throughout the entire hip area.Upon removing the poly from the cup, the cup had also dislodged from the bone.All implants had to be removed.New devices were then implanted successfully.

Manufacturer Narrative

An event regarding disassociation involving an accolade stem and a metal femoral head was reported.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.The dhr references (b)(4), which is in relation to "orange peel issue." this nc is not relevant to this investigation.Complaint history review: there have been no other events reported for the reported manufacturing lot.Conclusion: no allegation of failure was made against the reported device.Based on the information provided there is no indication that the product reported in this investigation contributed to the event.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 54MM
• Type of Device: 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4724028
• MDR Text Key: 5746091
• Report Number: 0002249697-2015-01353
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2011
• Device Catalogue Number: 502-01-54E
• Device Lot Number: 21173801
• Other Device ID Number: STER. LOT 0612NIRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2006
• 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: 73 YR