MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 6052-0935S

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.

Event Description

Dr.Revised a right total hip that was originally done on (b)(6) 2019.Patient had dislocated multiple times.Dr.Felt the cup was placed too vertically and the stem was undersized.He revised the entire hip to a trident ii multi-hole cup, mdm and omnifit hfx press fit stem.Update 13/january/2020: spoke to rep.Surgeon also felt that the implanted stem was undersized for the patient's anatomy and was revised.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #9
• Type of Device: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9678665
• MDR Text Key: 178325524
• Report Number: 0002249697-2020-00241
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07613327021127
• UDI-Public: 07613327021127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 6052-0935S
• Device Catalogue Number: 6052-0935S
• Device Lot Number: JN0J0E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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: 74 YR