MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 6942-5-046

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

Patient Problem Unspecified Infection (1930)

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: unitrax c-taper sleeve +0mm; cat#: 6942-7-065; lot#: 79170403.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that the patient's left unipolar hip was revised due to infection.A unitrax head and sleeve were revised.

• Brand Name: UNITRAX MODULAR ENDO HEAD 46MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15705261
• MDR Text Key: 302764143
• Report Number: 0002249697-2022-01575
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327032406
• UDI-Public: 07613327032406
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2022

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 Model Number: 6942-5-046
• Device Catalogue Number: 6942-5-046
• Device Lot Number: 5W714X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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: 93 YR
• Patient Sex: Female