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

Catalog Number 1236-2-244

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/20/2023

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 6260-9-122; 22.2mm std lfit v40 head; lot# 66978702; cat# 626-00-38d; modular dual mobility insert; lot# 67234403; cat# 502-11-48d; trident hemispherical cluster hole shell; lot# 67254303; cat# 6720-0230; size 2 accolade ii 132 deg; lot# 62478403.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Surgeon booked patient for hip revision following suspected hip infection.2x old components explanted, and 2x replacement items implanted.

• Brand Name: RESTORATION ADM X3 INS
• 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: 17709496
• MDR Text Key: 322924216
• Report Number: 0002249697-2023-01005
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2023

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: 10/31/2023
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 411309
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 60 KG