MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CUP 52MM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408); Malposition of Device (2616); Mechanical Jam (2983); Positioning Problem (3009)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 03/08/2017

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

Sales rep reported a right total hip revision due to pain and looseing of cup.

Manufacturer Narrative

An event regarding loosening and pain involving an unknown trident shell was reported.A review by a clinical consultant confirmed shell malposition, loosening and osteolysis in the acetabulum.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: a review by a clinical consultant noted: stable bone ingrowth position of stem although osteolysis is present in proximal medial and lateral femoral cortex.- the cup is loose with radiolucent lines and osteolysis around entire cup shell.The cup has adequate inclination but excessive anteversion as evident by the large projected oval of the cup opening circle.X-ray post event confirms cup loosening with radiolucent lines around the entire cup shell and osteolysis also in the proximal femur although securefit stem fixation remains excellent.The cup has an adequate inclination but excessive anteversion of some 41°.- the principal problem of this case is cup malposition leading to an overload condition with cup loosening.The reported pain of the patient is thus caused by cup loosening, quite evident on the only available x-ray of the hip.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 has a normal inclination of 45° but there is an excessive anteversion of some 41° where the normal range should be within 15° - 25° of anteversion.Conclusions: a review by a clinical consultant concluded: cup malposition in excessive anteversion has contributed to an overload condition in the arthroplasty increasing micromotion in the cup-bone interface and as such causing cup loosening requiring revision.Further information such as device details and additional x-rays are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Sales rep reported a right total hip revision due to pain and loosening of cup.

• Brand Name: UNKNOWN TRIDENT CUP 52MM
• Type of Device: HIP IMPLANT
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6457601
• MDR Text Key: 71678422
• Report Number: 0002249697-2017-01117
• Device Sequence Number: 1
• Product Code: LPH
• 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: 06/01/2017

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 Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• 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: 55 YR