MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY SECUR-FIT PLUS MAX #8/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6054-0814S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device noted as returned.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: delta c-taper head 28mm +0, cat#: 18-2800, lot#: 70156101.Restoration adm x3 ins 28/48, cat#: 1236-2-848, lot#: 72336201.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient experiencing hip pain post op, revision surgery performed.

• Brand Name: PRIMARY SECUR-FIT PLUS MAX #8/14
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14351025
• Report Number: 0002249697-2022-00681
• Device Sequence Number: 4077768
• Product Code: LZO
• UDI-Device Identifier: 07613327020854
• UDI-Public: 07613327020854
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K041170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: 11/30/2023
• Device Model Number: 6054-0814S
• Device Catalogue Number: 6054-0814S
• Device Lot Number: XM6DNX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female