MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SECUR-FIT STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 10/23/2022

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.

Event Description

It was reported that the patient's left hip was revised.Rep was told that the patient had an 'old' periprosthetic fracture which either healed or partially healed.Nothing further (i.E.Fracture, subsidence, etc) was reported to the rep.A stem, head and liner were revised to another stem, head, and liner.Rep confirmed there are no allegations against the revised head and liner.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding loosening involving an unknown securfit stem was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a revision left cementless total hip arthroplasty for subsidence and loosening of the femoral component.A probable periprosthetic fracture was present the age of which is unknown but it appears healed.I can confirm that the implant showed the above findings since i was able to see an x-ray demonstrating them.Since i do not have an operation report or any office notes, i cannot absolutely confirm that the revision took place but the inquiry summary described the revision.The root cause of revision of the femoral component is multifactorial.It cannot be determined with certainty.In this case the patient may well have had satisfactory fixation of the femoral component which may have then loosened secondary to a periprosthetic fracture.Other causes of femoral loosening include surgical technique factors, and patient factors such as activity level and bmi." 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.A review of the medical records by a clinical consultant confirmed stem loosening.An old periprosthetic fracture that had healed was observed by the clinician in the provided x-ray image - it is unknown if the periprosthetic fracture occurred while this stryker device was implanted in the patient.The clinician could not determine root cause from the information provided but indicated that "the patient may well have had satisfactory fixation of the femoral component which may have then loosened secondary to a periprosthetic fracture.Other causes of femoral loosening include surgical technique factors, and patient factors such as activity level and bmi." further information such as return of the device, pathology reports, 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.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.Product surveillance will continue to monitor for trends.

Event Description

It was reported that the patient's left hip was revised.Rep was told that the patient had an 'old' periprosthetic fracture which either healed or partially healed.Nothing further (i.E.Fracture, subsidence, etc) was reported to the rep.A stem, head and liner were revised to another stem, head, and liner.Rep confirmed there are no allegations against the revised head and liner.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN_SECUR-FIT STEM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15802267
• MDR Text Key: 303701101
• Report Number: 0002249697-2022-01635
• 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,Followup
• Report Date: 01/30/2023

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: 10/23/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/30/2023
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 50 KG