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Catalog Number UNK_KIE
Device Problem Malposition of Device (2616)
Patient Problems Failure of Implant (1924); Perforation (2001)
Event Date 09/01/2020
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated.
Event Description
The manufacturer became aware of a literature published by lincoln county hospital in united kingdom. The title of this report is ¿late medial migration of lag screw after gamma3 nailing threatening the internal iliac vessels¿ published on september 1, 2020, which is associated with the stryker ¿gamma3 nailing¿ system. The article can be found at http://dx. Doi. Org/10. 2106/jbjs. Cc. 19. 00623. 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 lag screw medial migration into the pelvis which required revision surgery. The report states: ¿eight months later, during investigations for unrelated vascular problems in the contralateral leg, it was identified that the lag screw on the left side had migrated medially into the pelvis and was in contact with the internal iliac vessels with complete collapse at the fracture site. She was reviewed urgently. A preoperative computed tomography angiogram was performed. This revealed that the screw was adjacent to the internal iliac vessels, and hence, a vascular team involvement was sought. After a multidisciplinary team meeting, it was decided to embolize the internal iliac vessels to prevent bleeding during the removal of screw and conversion to total hip replacement. The patient underwent successful embolization 2 days before the procedure. We approached the hip through a posterior approach. The nail was removed, and the hip joint was exposed. The lag screw was identified deep in the acetabulum and removed with no obvious bleeding from the screw track. Observation up to 10 minutes subsequent to the screw removal showed no hemodynamic compromise. We proceeded to reconstruct the hip using an uncemented implant. ¿.
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Type of DeviceIMPLANT
Manufacturer (Section D)
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
MDR Report Key12166257
MDR Text Key261643844
Report Number0009610622-2021-00592
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
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: 07/14/2021 Patient Sequence Number: 1