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

Catalog Number UNK_JR

Device Problem Malposition of Device (2616)

Patient Problems Injury (2348); Reaction (2414)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient's hip was revised.Surgeon reported that there was evidence of metallosis.Primary procedure was performed 10-12 years ago.Patient was revised to a restoration modular with a 32 biolox head.According to medical review, relevant procedure related factor to contribute to overload in the bearing section of the arthroplasty was clearly present with cup malposition in absent anteversion.

Manufacturer Narrative

An event regarding malposition involving an unknown implant trident shell and unknown liner 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: procedure-related factors: a review of the provided medical records and or x-rays by a clinical consultant indicated: despite the limited clinical information, it is clear that the cup has significant malposition in absent anteversion which is very relevant to the failure mechanism of this case: 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.Inclination of the cup is normal but in clinical practice anteversion issues play a much more important role to contribute to overload in the bearing section of the arthroplasty due to edge loading, impingement, subluxation or otherwise adverse biomechanical effects.Lack of cup anteversion promotes impingement in flexion and/or internal rotation representing a clear overload condition.Procedure-related factors: cup malposition in absent anteversion.Use of skirted femoral head as secondary contributing factor.Patient-related factors none evident, no info.Device-related factors: none.Diagnosis: cup malposition in absent anteversion with use of a skirted femoral head as secondary contributing factor has contributed to overload in the bearing section of the arthroplasty causing excessive micromotion between stem taper and femoral head leading to catastrophic taper damage as final effect with disassociation of the femoral head from the taper requiring revision.Device history review: not performed as the device lot number is unknown.Complaint history review: not performed as the device lot number is unknown.Conclusions: the medical review concluded; cup malposition in absent anteversion with use of a skirted femoral head as secondary contributing factor has contributed to overload in the bearing section of the arthroplasty causing excessive micromotion between stem taper and femoral head leading to catastrophic taper damage as final effect with disassociation of the femoral head from the taper requiring revision.No further investigation for this event is possible at this time.Further information including patient details, device details, return of device operative reports, & follow-up notes are needed to investigate this event further.If additional information become available, this investigation will be reopened.

Event Description

It was reported that patient's hip was revised.Surgeon reported that there was evidence of metallosis.Primary procedure was performed 10-12 years ago.Patient was revised to a restoration modular with a 32 biolox head.According to medical review, relevant procedure related factor to contribute to overload in the bearing section of the arthroplasty was clearly present with cup malposition in absent anteversion.

• Brand Name: UNKNOWN SHELL
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7153896
• MDR Text Key: 96013921
• Report Number: 0002249697-2017-03765
• 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: 01/05/2018

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 01/05/2018
• 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