MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-10-36G

Device Problems Contamination (1120); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.The following devices were also listed in this report: delta v-40 ceramic head 36/-2,5; cat#:6570-0-436; lot#:56050803; trident psl with purefix ha 60mm; cat#:542-11-60g; lot#:42553101; size 8 accolade ii 127 deg; cat#:6721-0837; lot#:53989503; 6.5 cancellous bone screw 30mm; cat#:2030-6530-1; lot#: k38y7y; 6.5 cancellous bone screw 30mm; cat#:2030-6530-1; lot#: ae8yw3.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.

Event Description

Patient showed signs of infection.After 2 previous washouts, surgeon elected to remove all components and implanted a depuy prostellac to help cure infection.

Manufacturer Narrative

An event regarding infection involving an trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: no medical information was received for review with the 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 similar relevant events for the reported lot or sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, pathology reports, operative reports, xrays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become 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

Patient showed signs of infection.After 2 previous washouts, surgeon elected to remove all components and implanted a depuy prostellac to help cure infection.

• Brand Name: TRIDENT 10° X3 INSERT 36MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6116224
• MDR Text Key: 60426252
• Report Number: 0002249697-2016-03696
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

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: 08/30/2021
• Device Catalogue Number: 623-10-36G
• Device Lot Number: HM6M1W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• 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: 42 YR
• Patient Weight: 115