MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIZE 7 RIGHT CITATION STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported the patient's right hip was revised due to trunnionosis.Intra-operatively, trunnion wear was observed.Due to the patient's height and weight, the surgeon wanted to revise as little as possible.The femoral head only was revised to a universal ceramic head with sleeve.

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.Device not returned to the manufacturer.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a lfit v40 cocr head that was mated with a citation stem was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 15 years after implantation due to trunnionosis.I can confirm that this event took place since i was able to review an x-ray showing the defect of the trunnion and disassociation/dislocation of the femoral head.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnionosis are multifactorial including surgical technique factors, patient factors including activity level and bmi, and implant factors.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: the reported unknown citation stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported the patient's right hip was revised due to trunnionosis.Intra-operatively, trunnion wear was observed.Due to the patient's height and weight, the surgeon wanted to revise as little as possible.The femoral head only was revised to a universal ceramic head with sleeve.*update on 09-may-2022 based on medical review: "[.] a document titled "x-ray" is provided.It is a photograph of an x-ray of an ap of a right hip of a cementless total hip replacement.The acetabular cup appears satisfactory.The femoral component appears well fixed.There is a disassociation of the femoral head from the trunnion with the head dislocated from the cup.There is a notch/defect in the superior portion of the trunnion.[.] ".

• Brand Name: UNKNOWN SIZE 7 RIGHT CITATION STEM
• 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 ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13150842
• MDR Text Key: 283140662
• Report Number: 0002249697-2022-00005
• Device Sequence Number: 1
• Product Code: MEH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2022

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: 12/08/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/30/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 159 KG