MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 1236-2-848

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding dislocation involving an adm liner was reported.The event was confirmed.Method & results: product evaluation and results: the device was not returned for evaluation.Medical records received and evaluation:review of medical records by a consulting clinician noted: "on (b)(6) 2015 and (b)(6) 2015 she sustained recurrent posterior dislocations of her left hip, treated with closed reduction.Product history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 3 other events for the lot referenced, however, they are for the same patient.Conclusions: review of medical records by a consulting clinician confirms dislocation as noted: "on (b)(6) 2015 she dislocated her left total hip and a closed reduction was performed.In this case complicated by polyarticular disease, steroid dependant asthma, and recurrent instability requiring acetabular revision to a larger shell, the preparation of the acetabulum for the larger component likely compromised the integrity of the medial porotic acetabular wall resulting in the protrusio and failure of fixation requiring the cage reconstruction.While the mri of (b)(6) 2014 is consistent with particle disease, it is not diagnostic, which would require histopathology, which is not diagnostic in this case.The modest elevation of cobalt and normal chromium levels is not unexpected in a patient with three major joint arthroplasties and does not necessarily represent pathology.Infections are often difficult to diagnose in total hip arthroplasty, and with the elevated esr and crp it was never completely ruled out.The combination of multiple surgeries, osteoporotic bone, muscle atrophy and incompetence, all contributed to the recurrent instability in this case.In the absence of examining the explanted components, no definitive case can be made that this complex clinical picture was the result of trunnionosis or factors related to component design, manufacturing or materials." the exact root cause could not be determined.Additional information such as examination of the explanted components are needed to further evaluate and determine a root case.If devices or additional information become available, this investigation will be reopened.

Event Description

Per medical review: "on (b)(6) 2015 she dislocated her left total hip and a closed reduction was performed.".

• Brand Name: RESTORATION ADM X3 INS 28/48
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7682469
• MDR Text Key: 113800839
• Report Number: 0002249697-2018-02152
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2018

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 266065
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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: 63 YR
• Patient Weight: 84