MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LINER 10 DEG HOODED-NEU, MP9, HXE-PLUS, 40MM; HIP SYSTEMS DJO SURGICAL

Catalog Number 932-40-756

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

Patient Problem Joint Dislocation (2374)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2018-01085; 932-36-752, s803 - dislocation, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Event Description

Revision surgery - mdr - dislocation.

• Brand Name: LINER 10 DEG HOODED-NEU, MP9, HXE-PLUS, 40MM
• Type of Device: HIP SYSTEMS DJO SURGICAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 18088686
• MDR Text Key: 327588187
• Report Number: 1644408-2023-01590
• Device Sequence Number: 1
• Product Code: OQG
• UDI-Device Identifier: 00888912100335
• UDI-Public: 00888912100335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 932-40-756
• Device Lot Number: 815N1990
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2023
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female