MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE 131MM; PLATE, FIXATION, BONE

Model Number 02.102.001

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history.Part number: 02.102.001.Lot number: 9944571.Manufacturing site: (b)(4).Release to warehouse date: 28.June 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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

It was reported that on (b)(6) 2020 the patient underwent removal of dynamic helical hip system (dhhs) followed by conversion of total hip replacement.The patient was originally implanted with the dhhs system on an unknown date.The procedure and patient outcomes are unknown.This is report 3 of 10 for (b)(4).This report is for a locking trochanteric stabilization plate.(b)(4) is linked to this complaint.

• Brand Name: UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE 131MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10395350
• MDR Text Key: 202564609
• Report Number: 2939274-2020-03481
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982028976
• UDI-Public: (01)10886982028976
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.102.001
• Device Catalogue Number: 02.102.001
• Device Lot Number: 9944571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 130 DEG LCP® DHHS(TM) SIDEPLATE-4 HOLES; HELIX BLADE 100MM; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention