MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE ECCENTRIC INSERT 10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number S-2301C-2846

Device Problem Fracture (1260)

Patient Problems Subluxation (4525); Insufficient Information (4580)

Event Date 02/20/2024

Event Type  Injury  

Event Description

Patient reported a right hip revision due to liner breaking.Head, cup and insert revised to a larger size.

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Manufacturer Narrative

Device information received.Reported event: an event regarding crack/fracture involving an other hip liner was reported.The event was confirmed via medical review.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: clinician review: a review of the provided medical records by a clinical consultant indicated: at and undisclosed distant date the patent had a primary hip replacement with trochanteric cabling performed.This went on to be significantly painful and on 4/5/23 a revision surgery was performed with exchange of the shell, liner and femoral head.The surgeon noted in his operative report that the acetabular liner had fractured and there was wear of the anterior portion of the metal acetabular shell.As a result, there was extensive metallosis throughout the joint needing extensive debridement.7 months later the patient again had a fractured liner requiring a second revision.The surgeon did not opine as to the reason for this early failure of the polyethylene liner.It is confirmed the patient underwent two revision tha surgeries due to mechanical complication of a tha.Medical review addendum: this review demonstrated radiographic evidence of lateral subluxation of the hip consistent with liner breakage, there is further radiographic and implant sheet evidence confirming revision surgery.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to crack/fracture of the liner.At and undisclosed distant date the patent had a primary hip replacement with trochanteric cabling performed.This went on to be significantly painful and on (b)(6) 2023 a revision surgery was performed with exchange of the shell, liner and femoral head.The surgeon noted in his operative report that the acetabular liner had fractured and there was wear of the anterior portion of the metal acetabular shell.As a result, there was extensive metallosis throughout the joint needing extensive debridement.7 months later the patient again had a fractured liner requiring a second revision.The surgeon did not opine as to the reason for this early failure of the polyethylene liner.It is confirmed the patient underwent two revision tha surgeries due to mechanical complication of a tha.Medical review addendum: this review demonstrated radiographic evidence of lateral subluxation of the hip consistent with liner breakage, there is further radiographic and implant sheet evidence confirming revision surgery.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

Patient reported a right hip revision due to liner breaking.Head, cup and insert revised to a larger size.

• Brand Name: CROSSFIRE ECCENTRIC INSERT 10
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18921739
• MDR Text Key: 337873899
• Report Number: 0002249697-2024-00433
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327022810
• UDI-Public: 07613327022810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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: S-2301C-2846
• Device Lot Number: 194168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 73 KG