MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUS; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 2051-2050P

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Injury (2348)

Event Date 11/13/2018

Event Type  Injury  

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.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Device not returned.

Event Description

It was reported that patient's left hip was revised due to all components loosening.Patient was revised to a restoration modular stem construct, stryker head and liner, and trident ii shell.

• Brand Name: SECUR-FIT HA PSL CUP/CLUS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: anna smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8152439
• MDR Text Key: 129966043
• Report Number: 0002249697-2018-03975
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327038217
• UDI-Public: 07613327038217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2018

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: 02/28/2004
• Device Catalogue Number: 2051-2050P
• Device Lot Number: 38606801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/1999
• 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: 67 YR