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 10/06/2014

Event Type  Injury  

Event Description

Postoperative diagnosis: infected right total hip arthroplasty: all components from index surgery were revised.

Manufacturer Narrative

(b)(6).An event regarding infection involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned for analysis.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot and sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was received.Further information such as return of device, pathology report, x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.If additional information becomes available, this investigation will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.

Event Description

Postoperative diagnosis: infected right total hip arthroplasty: all components from index surgery were revised.

Manufacturer Narrative

Additional devices listed in this report: cat # 540-11-50e, lot # 47825001, description: trident psl ha solid back 50mm; cat # 6570-0-136, lot # 48281701, description: delta v-40 ceramic head 36/0; cat # 6720-0535, lot # 46262504, description: size 5 accolade ii 132 deg.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

• 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: 4626903
• MDR Text Key: 5735766
• Report Number: 0002249697-2015-00887
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

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: 07/31/2019
• Device Catalogue Number: 623-00-36E
• Device Lot Number: MNKW49
• Other Device ID Number: STER. LOT MSGNK28D3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 69