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

Model Number 1236-2-852

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned to the manufacturer.

Event Description

As reported: "patient states there is a lot of muscle pain around the hip area, using a cane to walk but is limited by ankle pain and swelling." clinic notes indicate: "loosening of hip joint prosthesis.Mechanical loosening of internal left hip prosthetic joint.Wear of articular bearing surface of internal prosthetic.".

Manufacturer Narrative

Update to patient id, date of explant, & outcomes attributed to ae.Reported event: an event regarding wear involving an adm liner was reported.Method & results:  -device evaluation and results: not performed as the device was not returned.-clinician review: a review of medical records by a clinical consultant indicated: "the patient underwent a revision operation and then developed drainage which required another surgery and liner and head exchange.Subsequent cultures were positive for infection.I can confirm that the debridement and the liner and head exchange took place since i was able to review the operation report and pathology reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of drainage and infection following total hip hyperplastic are multifactorial including surgical technique factors and patient factors." -device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.   -complaint history review: there have been no other similar events for the reported lot.  conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device 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.Product surveillance will continue to monitor for trends.

Event Description

As reported: "patient states there is a lot of muscle pain around the hip area, using a cane to walk but is limited by ankle pain and swelling." clinic notes indicate: "loosening of hip joint prosthesis.Mechanical loosening of internal left hip prosthetic joint.Wear of articular bearing surface of internal prosthetic.".

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14160397
• MDR Text Key: 289675060
• Report Number: 0002249697-2022-00542
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1236-2-852
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 81833901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White