MAUDE Adverse Event Report: SYNTHES GMBH BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.168.280S

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

Patient Problems Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent a surgery.After surgery, on (b)(6) 2022, necrosis of the femoral head was confirmed.There is a plan to perform a revision surgery via bha or tha, but it has not been decided at this point.Also to note is that necrosis of the femoral head is not due to an implanted product, and necrosis of the femoral head occurs at the time of injury or unavoidably after injury in most of the cases.No further information is available.This report is for one (1) bolt f/fem neck syst f/construct length this is report 2 of 4 for complaint (b)(4).

• Brand Name: BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; 3035526892
• MDR Report Key: 14846527
• MDR Text Key: 295114764
• Report Number: 8030965-2022-04436
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089823
• UDI-Public: (01)07612334089823
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.280S
• Device Lot Number: 309P498
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention