MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 540-11-54F

Device Problems Mechanical Problem (1384); Malposition of Device (2616); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Unstable total hip.Converted to mdm construct.

Manufacturer Narrative

Reported event: an event regarding instability of a trident shell was reported.A review of the provided x-rays and medical notes by a clinical consultant confirmed shell malposition.Method & results: -device evaluation and results: not performed as device not returned.-medical records received and evaluation: a review of the provided x-rays and medical notes by a clinical consultant concluded: procedure-related factors: - cup malposition in low inclination and absent anteversion (or even retroversion).Patient-related factors: - none evident.Device-related factors: - none.Diagnosis: - cup malposition in low inclination and absent anteversion has contributed to an overload condition in the arthroplasty leading to impingement and/or subluxation with longstanding pain requiring cup revision.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot conclusions: a review of the provided x-rays by a clinical consultant concluded: "cup malposition in low inclination and absent anteversion has contributed to an overload condition in the arthroplasty leading to impingement and/or subluxation with longstanding pain requiring cup revision." no further investigation for this event is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Unstable total hip.Converted to mdm construct.

• Brand Name: TRIDENT PSL HA SOLID BACK 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6329130
• MDR Text Key: 67371873
• Report Number: 0002249697-2017-00552
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983382
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 540-11-54F
• Device Lot Number: 6MTMDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2008
• 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: 69 YR
• Patient Weight: 102