MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID28 OD44; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 63092844

Device Problems Detachment Of Device Component (1104); Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

Early loosening of the exeter rimfit cup was reported.The hospital used the rimcutter, and has experienced loosening.The loosening occurred at approximately one year post surgery.

Manufacturer Narrative

An event regarding cup loosening involving an exeter rimfit cup was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as no items were returned.Medical records received and evaluation: the medical review indicated that several factors relating to surgical technique of cementation have been discussed and together have caused a problem with optimal placement of the cemented rimfit cup.Too much cement was left behind the cup resulting in a cement mantle that became too thick and caused thermal necrosis of the opposing bone which after slow resorption caused the cup to become loose.Because cementation technique is the responsibility of the surgeon, root cause of failure is procedure-related.There is no evidence of patient-related or device-related factors.Device history review: not performed as no lot code information was provided.Complaint history review: not performed as no lot code information was provided.Conclusions: the medical review indicated that several factors relating to surgical technique of cementation have caused a problem with optimal placement of the cemented rimfit cup.A thick cement mantle behind the cup caused thermal necrosis of the opposing bone which after slow resorption caused the cup to become loose.There was no evidence of patient-related or device-related factors.No further investigation for this event is possible at this time.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Update: it should read: ¿(b)(6) hospital have used the exeter rimfit cup for 5 years, and have seen some early loosening of the cup.They approached me with this information, and have stopped using the exeter rimfit cup for the time being¿.

• Brand Name: EXETER X3 RIMFIT ID28 OD44
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5315941
• MDR Text Key: 34038046
• Report Number: 0002249697-2015-04428
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K111848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

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: 63092844
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• 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