MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 7236-2-852

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374); Inadequate Osseointegration (2646)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

An event regarding disassociation involving an adm liner was reported.The event was not 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: no medical records were received for review with a clinical consultant.-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 disassociation of the ceramic head from the adm liner.Loosening of the stem, periprosthetic fracture around the acetabular shell, and movement of the shell were also reported.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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.

Event Description

As reported: "please find attached information from index and revision surgeries of a right total hip.The revision was secondary to dislocation.It was discovered that the ceramic head disassociated from the poly insert.Also discovered was a crack in the acetabulum and the appearance that the cup had moved.It was also determined that the stem was loose.All implants were removed.A multihole cup was implanted with multiple screws and an mdm liner.The femur was prepared for an insignia stem and trialed.The hip remained grossly unstable so it was decided to leave the patient with a girdlestone.The plan being to come back after the cup has healed and place a rest mod with constrained liner.No further information available from the doctor or hospital.".

• Brand Name: RESTORATION ADM X3 INS 28/52
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17735200
• MDR Text Key: 323249990
• Report Number: 0002249697-2023-01026
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327315967
• UDI-Public: 07613327315967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182468
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7236-2-852
• Device Lot Number: 10139551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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: 80 YR
• Patient Sex: Male