MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6052-0625S

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Fatigue (1849); Unspecified Infection (1930); Pain (1994); Rash (2033); Thyroid Problems (2102); Ambulation Difficulties (2544)

Event Date 08/16/2014

Event Type  Death  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Review of the device history records indicates that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Its alleged by the patient's son, through the filing of a legal claim, that the patient underwent a right hip hemiarthroplasty on (b)(6) 2014.It is further alleged that after implantation the patient experienced pain, infection, thyroid problems, leg length discrepancy, weight gain, skin rashes and fatigue.Patient subsequently died.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #6
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7868352
• MDR Text Key: 119949440
• Report Number: 0002249697-2018-02838
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07613327021097
• UDI-Public: 07613327021097
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2018

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: 04/30/2015
• Device Catalogue Number: 6052-0625S
• Device Lot Number: MJEHAX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2010
• 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): Death