MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LAG SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Hospital policy.

Event Description

It was reported that patient's left femur was revised due to subsidence.Rep reported that the lag screw ripped through the femoral head.Patient was revised to a total hip construct.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.Implantation period of 1 year without event suggests correct implant placement but actually a typical cut out.

• Brand Name: UNKNOWN LAG SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8081164
• MDR Text Key: 127536214
• Report Number: 0009610622-2018-01404
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/16/2018

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: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/16/2018
• 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): Required Intervention
• Patient Age: 84 YR