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

Model Number	1236-2-244
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: modular dual mobility insert; 626-00-38d; 68932304.22.2mm + 3mm v40 head; 6260-4-222; 72836101.19mm x 217mm bowed plasma stem restoration modular hip system; 6276-5-419; 65804202.29mm mod rev hip body/bolt std component level 9006-1-029; 6276-1-029; 68236403.6.5 cancellous bone screw 40mm; 2030-6540-1; 421w03.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Procedure: the patient underwent left total hip arthroplasty outside cors scope.Patient was revised due to femoral loosening on (b)(6) 2019.Patient developed pji and all components where removed on (b)(6) 2020.Patient underwent reimplantation on (b)(6) 2020.

• Brand Name: RESTORATION ADM X3 INS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10458141
• Report Number: 0002249697-2020-01747
• Device Sequence Number: 2862353
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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 Expiration Date: 05/01/2021
• Device Model Number: 1236-2-244
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 315298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 52