MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 44MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 6942-5-044

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

Patient Problem Unspecified Infection (1930)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

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.The following devices were also listed in this report: unitrax c-taper sleeve +10mm; cat # 6942-7-085; lot # 90305501.Omnifit eon 127; cat # 6097-0735; lot # 4y1n4m.How fem/dist centralizer 13mm; cat # 6259-8-130; lot # 66340201.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 the patient's left hip was revised due to infection.A unitrax head and sleeve were revised.Rep provided primary and revision usage and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNITRAX MODULAR ENDO HEAD 44MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15459892
• MDR Text Key: 300296096
• Report Number: 0002249697-2022-01386
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327032383
• UDI-Public: 07613327032383
• 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: 09/20/2022

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: 6942-5-044
• Device Catalogue Number: 6942-5-044
• Device Lot Number: E42Y5M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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: 91 YR
• Patient Sex: Female
• Patient Weight: 64 KG