MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 502-03-54E

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding malposition and loosening involving a trident shell was reported.The event of malposition was confirmed.Loosening was not confirmed.Method & results: -product evaluation and results: visual inspection, dimensional, functional and material analysis could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant indicated " this patient underwent a primary right total hip arthroplasty at some point in the past.The patient developed a loosening of the acetabular component which necessitated revision surgery of the cup, and replacement of the femoral head component.I can confirm that the patient developed a problem with the right total hip as i was able to see the x-ray with the cup completely vertical.Loosening cannot be determined based on the x-ray provided.I cannot confirm that the revision took place since i have no documentation except the date of explantation as provided in the product inquiry summary.I have no surgeon notes or operation reports.The root causes of acetabular loosening are multifactorial and dependent on when the loosening occurs.These factors include surgical technique factors, and patient factors including bmi and activity level.If loosening occurs in the early postoperative period, then surgical technique factors would most likely be a likely cause.I would not assign any causality to the implant based on information reviewed [.]" -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 shell loosening.A review of medical records with a clinical consultant indicated " this patient underwent a primary right total hip arthroplasty at some point in the past.The patient developed a loosening of the acetabular component which necessitated revision surgery of the cup, and replacement of the femoral head component.I can confirm that the patient developed a problem with the right total hip as i was able to see the x-ray with the cup completely vertical.Loosening cannot be determined based on the x-ray provided.I cannot confirm that the revision took place since i have no documentation except the date of explantation as provided in the product inquiry summary.I have no surgeon notes or operation reports.The root causes of acetabular loosening are multifactorial and dependent on when the loosening occurs.These factors include surgical technique factors, and patient factors including bmi and activity level.If loosening occurs in the early postoperative period, then surgical technique factors would most likely be a likely cause.I would not assign any causality to the implant based on information reviewed.The explanted components should be submitted to stryker engineers for examination and analysis." malposition was confirmed but from the given information, it could not be determined whether it was initially implanted in that position or loosened and thus moved to a vertical position.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.

Event Description

It was reported that the patient's right hip was revised due to shell loosening.A shell, mdm metal liner, adm/ mdm poly insert, and femoral head were revised to competitor acetabular components and stryker femoral head.There were no allegations against the revised head or liner construct.Rep can provide pictures and confirmed that otherwise, no further information will be released by the hospital or surgeon.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16850667
• MDR Text Key: 314350496
• Report Number: 0002249697-2023-00454
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040142
• UDI-Public: 07613327040142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2023

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 Model Number: 502-03-54E
• Device Catalogue Number: 502-03-54E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/01/2023
• 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: Female
• Patient Weight: 102 KG