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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0002249697-2024-00468
• Device Sequence Number: 6826784
• Product Code: MEH
• UDI-Device Identifier: 07613327315967
• UDI-Public: 07613327315967
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female