MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-10-36F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/24/2014

Event Type  Injury  

Event Description

It was reported that patient had 5th revision of left hip due to infection.Doctor removed and replaced antibiotic spacer, head and liner.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown liner.Catalog numbers and lot codes of other devices listed in this report: cat.No.6364-2-036, v40(tm).Femoral head, lot code: g3202397; cat.No.0580-1-240, exeter v40 240mm lg 44mm no 3, lot code: g3084724; cat.No.3704-0-510, 2.0mm 22-13-5 ss cable/slv set, lot code: 47019112; cat.No.3704-0-510, 2.0mm 22-13-5 ss cable/slv set, lot code: 47987703; cat.No.3704-0-510, 2.0mm 22-13-5 ss cable/slv set, lot code: 47203505; cat.No.6197-9-001, simplex p with tobramycin 1 pack, lot code: mcv022.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device not returned to manufacturer.

Event Description

It was reported that patient had 5th revision of left hip due to infection.Doctor removed and replaced antibiotic spacer, head and liner.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding infection involving a trident liner was reported.The event was confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation.Medical records received and evaluation: a medical review was performed and concluded that the reported event was not device related.Device history review: records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot or sterile lot.Conclusions: the investigation concluded that this event was the first stage of a two stage infection treatment.A review by the clinical consultant indicated the removal of all devices was planned ahead as first stage of a two-stage infection treatment and as such was procedure-related.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

It was reported that patient had 5th revision of left hip due to infection.Doctor removed and replaced antibiotic spacer, head and liner.

• Brand Name: TRIDENT 10° 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4346239
• MDR Text Key: 18289462
• Report Number: 0002249697-2014-04783
• Device Sequence Number: 1
• Product Code: MEH
• 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,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 623-10-36F
• Device Lot Number: MNKEWW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• 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: 67 YR
• Patient Weight: 81