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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/23/2024

Event Type  Injury  

Event Description

Right hip revision was secondary to infection.The joint was opened, the liner, insert, a 15mm screw and the competitor head were all removed.The wound was washed out and a new insert, liner and competitor head were placed.

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.The following devices were also listed in this report: device name#tridentii tritanium multi 58f ; cat#709-04-58f; lot#97840101a.Device name#6.5mm low profile hex screw 15mm ; cat#7030-6515 ; lot#u7sk.Device name#6.5mm low profile hex screw 15mm ; cat#7030-6515 ; lot#uase.Device name#6.5mm low profile hex screw 20mm ; cat#7030-6520 ; lot#uepd.Device name#6.5mm low profile hex screw 20mm ; cat#7030-6520 ; lot#u7fh.Device name#6.5mm low profile hex screw 30mm ; cat#7030-6530 ; lot#fe9d.Device name#modular dual mobility insert ; cat#626-00-46f; lot#15039153.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18937326
• MDR Text Key: 338072980
• Report Number: 0002249697-2024-00468
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 13426651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female