MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 20MM; SCREW, FIXATION, BONE

Model Number 2030-6520-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 01/23/2023

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.It cannot be determined which one of the three screws allegedly damaged liner.Therefore, one screw will be reported and other screw information provided are as follows: device name#6.5 cancellous bone screw 20mm ; cat#2030-6520-1; lot#mmjhl4.Device not returned to the manufacturer.

Event Description

There was backside wear-like osteolysis around the screw hole of trident cup.An indentation made by the screw head was observed on the backside of the liner.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 20MM
• Type of Device: SCREW, FIXATION, BONE
• 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: 16383279
• MDR Text Key: 309634378
• Report Number: 0002249697-2023-00160
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327036985
• UDI-Public: 07613327036985
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K873251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2030-6520-1
• Device Catalogue Number: 2030-6520-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR
• Patient Sex: Male