MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACETABULAR SHELL/CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Malposition of Device (2616)

Patient Problem Joint Dislocation (2374)

Event Date 07/18/2023

Event Type  Injury  

Manufacturer Narrative

An event regarding malposition involving an unknown shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "document x-ray to pt xx.Jpg: this is a single x-ray image.The same dual geometry cup is present.It appears slightly vertical.There is no significant polyethylene wear noted on x-ray.The femoral component appears well fixed and well positioned.This patient underwent a cementless left total hip arthroplasty at some point in the past and then developed dislocation which required revision.I can confirm that the patient underwent a primary left total hip arthroplasty since i was able to review the x-rays.I cannot confirm that a revision was carried out since i have no supporting documentation, including office notes, operation notes, or post revision x-rays.The root cause of this event cannot be determined with certainty.The causes of late total hip arthroplasty dislocation are multifactorial including surgical technique factors and patient factors including activity level and bmi.Implant factors can be considered if there was, for example, significant polyethylene wear which contributed to dislocation.Otherwise i would not attribute any cause to the implant itself.Late location most likely occurs when significant polyethylene wear occurs and/or patient soft tissues stretch, allowing dislocation." 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: it was reported that the patient was revised due to dislocation of the head from the liner.The issue was addressed by explanting the head and the liner and cementing a new liner into the existing cup to alter the version.A review of the provided x-ray images indicated that the shell did appear "slightly vertical" but the dislocation event itself could not be confirmed as the x-rays did not display dislocation of the head/liner.It is likely that the mal-positioning of the shell caused or contributed to the subsequent dislocation.Further information such as device-identifying catalog and lot codes, additional pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.It should be noted that, although catalog numbers are unknown so surgical protocols/ifus could not be reviewed to confirm, cementing of a liner into the shell is generally considered an off-label application.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text: device not returned to the manufacturer.

Event Description

As reported: "revised a left hip liner and head of an old dual geometry cup and morse 28+5 head due to dislocation.Cemented in a liner to the existing cup to alter the version.No allegations made against the implants." rep confirmed the head came out of the liner.

• Brand Name: UNKNOWN ACETABULAR SHELL/CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17547750
• MDR Text Key: 321145189
• Report Number: 0002249697-2023-00889
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2023

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: 07/18/2023
• Initial Date FDA Received: 08/15/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male