MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-848

Device Problem Unstable (1667)

Patient Problems Muscle Weakness (1967); Pain (1994); Paralysis (1997); Joint Dislocation (2374)

Event Date 11/22/2022

Event Type  Injury  

Event Description

Patient had an index left tha outside of cors scope.Patient had aseptic loosening of the femoral component and malunion of a femoral periprosthetic fracture.The patient was revised on (b)(6)2020.Now the patient complains of pain and is diagnosed with chronic instability.The patient undergoes revision on (b)(6)2022.The proximal femoral replacement and the mdm components were exchanged.The acetabular cup and other components of the proximal femoral component (extension piece and stem) were retained.The patient was stabilized with a constrained liner.

Manufacturer Narrative

An event regarding instability 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: "the documentation provided confirms the series of events described in the event description.The patient did have a severe malunion deformity of the primal femur following plating of a periprosthetic fracture.They then underwent revisions for instability and ended up with a constrained liner.The root cause for peri-prosthetic fracture and subsequent surgeries cannot be determined from this limited documentation." 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 instability.A review of the provided medical information by a clinical consultant indicated: "the documentation provided confirms the series of events described in the event description.The patient did have a severe malunion deformity of the primal femur following plating of a periprosthetic fracture.They then underwent revisions for instability and ended up with a constrained liner.The root cause for peri-prosthetic fracture and subsequent surgeries cannot be determined from this limited documentation." it was further reported that the patient had muscle weakness and paralysis from recent spine procedures, and this may have contributed to the device failure.Intraoperatively, it was reported that "[the patient's] abductors were significantly atrophied and weak." 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.The following devices were also listed in this report: cat# 626-00-42e; modular dual mobility insert; lot# 77190804.Cat# 6570-0-128; delta v-40 ceramic head 28/0; lot# 77508305.Cat# 64951001; proximal fem comp std; lot# h322d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned to the manufacturer.

• Brand Name: RESTORATION ADM X3 INS 28/48
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17495862
• MDR Text Key: 320759401
• Report Number: 0002249697-2023-00886
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 77832501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 52 KG