MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 40MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 6942-5-040

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

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.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.Device not returned.

Event Description

It was reported through the submission of a revision usage sheet that the patient's left hip was revised.Spoke to rep: patient was revised due to protrusio.A 40mm unitrax head and +4 mm sleeve were revised with no allegations against the sleeve.Patient was revised to a stryker head with competitor acetabular components.

• Brand Name: UNITRAX MODULAR ENDO HEAD 40MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: 12860360
• MDR Text Key: 281138266
• Report Number: 0002249697-2021-01954
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327032345
• UDI-Public: 07613327032345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014226
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 6942-5-040
• Device Catalogue Number: 6942-5-040
• Device Lot Number: 692LJL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 20 KG