MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number 7236-2-854

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation involving an adm liner was reported.The event was confirmed via clinician review of the provided medical records.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 case concerns a 73-year-old male who underwent a primary total hip arthroplasty and then required revision surgery slightly over two months afterwards.This was performed for dislocation but no other information is provided.I can confirm that the patient underwent a primary total hip arthroplasty and also sustained a dislocation.[¿] the causes of early dislocation following total hip arthroplasty are multifactorial.They include surgical technique factors, patient factors including the ability to follow postoperative instructions, activity level and bmi as well as possible implant factors.The root cause of this event cannot be determined with certainty.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination to determine if any defects were present.In my opinion that would be highly unlikely.I believe this location in the early postoperative period is usually related to surgical technique factors with failure to restore proper soft tissue tension in the thigh with possible impingement.Other factors could include abductor mechanism insufficiency and soft tissue imbalance." 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.A review of the provided medical information by a clinical consultant indicated the following: "this case concerns a 73-year-old male who underwent a primary total hip arthroplasty and then required revision surgery slightly over two months afterwards.This was performed for dislocation but no other information is provided.I can confirm that the patient underwent a primary total hip arthroplasty and also sustained a dislocation.[¿] the causes of early dislocation following total hip arthroplasty are multifactorial.They include surgical technique factors, patient factors including the ability to follow postoperative instructions, activity level and bmi as well as possible implant factors.The root cause of this event cannot be determined with certainty.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination to determine if any defects were present.In my opinion that would be highly unlikely.I believe this location in the early postoperative period is usually related to surgical technique factors with failure to restore proper soft tissue tension in the thigh with possible impingement.Other factors could include abductor mechanism insufficiency and soft tissue imbalance." 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.H3 other text : not available.

Event Description

It was reported that the patient's right hip was revised.As reported: "was noticed on film and interop that the poly head had disassociated from the inner ceramic bearing.No other information available due to hospital policy.New mdm head construct reimplanted.".

• Brand Name: RESTORATION ADM X3 INS 28/54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17076197
• MDR Text Key: 316676559
• Report Number: 0002249697-2023-00636
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327315820
• UDI-Public: 07613327315820
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7236-2-854
• Device Catalogue Number: 7236-2-854
• Device Lot Number: 94518201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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: 73 YR
• Patient Sex: Male