MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CUP; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Malposition of Device (2616); Positioning Problem (3009); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient had revision of the left hip.The surgeon felt there was excessive bone growth in the patient.He removed bone, cleaned the area and implanted new items.Operative reports diagnosis of "discomfort with mechanical squealing.".

Manufacturer Narrative

An event regarding audible noise involving an unknown trident shell was reported.Shell malposition was confirmed following a review by a clinical consultant.Method & results: device evaluation and results: was not performed as the device was not returned medical records received and evaluation: a medical review by a clinical consultant concluded; revision of a trident cup with ceramic bearing due to pain, squeaking, popping and heterotopic ossifications some 11-years post implantation in a male patient of (b)(6) (1964) with mild overweight (bmi = (b)(6)) and unknown activity level.No actual x-rays are available for review but the medical records document a ¿neutro-verted¿ cup with heterotopic ossifications (ho) in the joint, brooker grade-iv.Revision surgery was performed although no surgical details are available and no explants were returned for investigation.[.] [.]the ¿neutro-verted¿ cup indicates this cup had malposition.Total hip components require positioning for optimal rom.Normal cup position is around 45° of inclination (abduction) and some 20° of anteversion, a bit depending upon approach to the hip and surgeon preference.The stem should have an anteversion around 15°, again depending upon surgical approach and stem design.In this case, the cup had reportedly no anteversion where normal range should be within 15° - 25° of anteversion although exact values were not reported but the term neutroversion is clear enough to establish the problem.[.] device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.Conclusions: a review by a clinical consultant concluded: [.]procedure-related factors: cup malposition in neutroversion.Heterotopic ossifications represent a procedure-related complication, generic to hip arthroplasty with sometimes additional patient-related risk factors.Patient-related factors.Patient-related risk factors are sometimes associated with ho formation.Device-related factors: none.Diagnosis: cup malposition in neutroversion in an adverse combination with heterotopic ossifications in the arthroplasty have contributed to abnormal biomechanical conditions in the arthroplasty with overload in the ceramic articulation causing quite likely a wear scar with development of squeaking.The earlier presence of popping would further support the presence of abnormal biomechanics in the arthroplasty with impingement and/or micro-separation.If additional information and/or device become available, this investigation will be reopened.

Event Description

Patient had revision of the left hip.The surgeon felt there was excessive bone growth in the patient.He removed bone, cleaned the area and implanted new items.Operative reports diagnosis of "discomfort with mechanical squealing.".

• Brand Name: UNKNOWN TRIDENT CUP
• Type of Device: HIP 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6373356
• MDR Text Key: 68846448
• Report Number: 0002249697-2017-00779
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR
• Patient Weight: 92