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

Catalog Number UNK_KIE

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Perforation (2001); Hip Fracture (2349); Implant Pain (4561)

Event Date 12/29/2014

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged postoperative lag screw migration into the pelvis with no trauma mentioned in the article could be confirmed through the x-rays provided in the given article. More information as well as the affected device must be available to determine the exact root cause of the failure. However, based on past complaint history, the most probable root cause of the migration of lag screw is the inadequate locking of the lag screw with the set screw in the nail, which is user related. If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly. Device disposition is unknown.

Event Description

The manufacturer became aware of a literature published by department of orthopedics, institute of health biosciences, the university of tokushima graduate school, japan. The title of this report is ¿intrapelvic migration of the lag screw in intramedullary nailing¿ published on december, 29th 2014, which is associated with the stryker ¿gamma3 nailing¿ system. The article can be found at http://dx. Doi. Org/10. 1155/2014/519045. This report includes research done on 1 patient. It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints. Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report. This product inquiry addresses postoperative lag screw migration into the pelvis with no trauma. The patient was subsequently treated with lag screw removal and revision surgery with total hip arthroplasty. The report states: ¿at 6 weeks after the first operation, she returned to the hospital with a 1-week history of progressive pain in her left hip, but no trauma. Radiography revealed redisplacement of the fracture and intrapelvic migration of the lag screw through the femoral head and the medial wall of the acetabulum, which was separated from the nail body. She was referred to our hospital for revision surgery. We scheduled a 2-stage operation. First, the migrated lag screw was removed without injury to other pelvic structures. 3 weeks after the removal surgery, cementless total hip arthroplasty with an autologous bone graft for the bony defect in the acetabulum due to lag screw penetration was performed. ¿.

• 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12777661
• MDR Text Key: 280510360
• Report Number: 0009610622-2021-00777
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• 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 Treatment Data

Date Received: 11/09/2021 Patient Sequence Number: 1