MAUDE Adverse Event Report: ENCORE MEDICAL L.P AR, SMALL SOCKET INSERT, 32MM NEUTRAL +4 EPLUS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number 400-01-292

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

Patient Problem Joint Dislocation (2374)

Event Date 08/20/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2019-00927; 400-01-296, 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 - due to dislocation.

• Brand Name: AR, SMALL SOCKET INSERT, 32MM NEUTRAL +4 EPLUS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17761627
• MDR Text Key: 323579124
• Report Number: 1644408-2023-01264
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00888912075695
• UDI-Public: 00888912075695
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N980003
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400-01-292
• Device Lot Number: 468451
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2023
• Initial Date FDA Received: 09/15/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 470-02-150 LOT: 596151
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male