MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-00-36E

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2014

Event Type  Injury  

Event Description

Infection components were explanted due to infection and restoration modular components were implanted on left hip.

Manufacturer Narrative

The following other hip devices were also listed in this report: size 3 accolade ii 127 deg; cat# 6721-0330; lot# mmt28d.Trident psl ha cluster 50mm; cat# 542-11-50e; lot# mmp47l.Delta v-40 ceramic head 36/0; cat# 6570-0-136; lot# 46088701.Cancellous bone screw 6.5mm; cat# 2030-6525; lot# mmr2hj.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

Correction cancellous bone screw 6.5mm; cat# 2030-6525; lot# mmr2hj should be 6.5 cancellous bone screw 25mm; cat# 2030-6525-1; lot# mmr2hj.An event regarding infection involving a trident 0° x3 insert 36mm id was reported.The event was not confirmed.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: a complaint history review confirmed no other similar events for the reported lot or sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.

Event Description

Infection components were explanted due to infection and restoration modular components were implanted on left hip.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• Type of Device: 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3714172
• MDR Text Key: 4230385
• Report Number: 0002249697-2014-00995
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• 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: 03/07/2014

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 Expiration Date: 01/31/2019
• Device Catalogue Number: 623-00-36E
• Device Lot Number: MMT28D
• Other Device ID Number: STERILE LOT# MSGNA06A5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 03/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• 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
• Patient Age: 55 YR
• Patient Weight: 114