MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 0 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 2043C-2854

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Pain (1994)

Event Date 01/08/2015

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: accolade tmzf hip stem #5; cat# 6020-0537; lot# 42373203.Secur-fit ha psl cup/clustr shell 56mm; cat# 2051-2056; lot# mna961.28mm +4 lfit v40 head; cat# 6260-9-228; lot# 43927701.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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.Device not returned.

Event Description

A hospital representative called on a patient's behalf inquiring about a recall for the patient's left hip implants.Update 11-april-2019: patient called stating patient has arthritis around the joint and feels pain when walking.

• Brand Name: CROSSFIRE 0 DEG INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8591747
• MDR Text Key: 144444749
• Report Number: 0002249697-2019-01872
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540037183
• UDI-Public: 04546540037183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2019

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: 10/31/2019
• Device Catalogue Number: 2043C-2854
• Device Lot Number: 49629101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2014
• 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): Other
• Patient Age: 53 YR