MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENTRALIZER 10.0MM; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number 1376-48-000

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

Patient Problem Unspecified Infection (1930)

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported that the surgeon did an implant exchange due to infection.The surgeon implanted a prostalac implant.Doi: (b)(6) 2021; dor: (b)(6) 2022; affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: CEMENTRALIZER 10.0MM
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13731891
• MDR Text Key: 287000378
• Report Number: 1818910-2022-04489
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 10603295034568
• UDI-Public: 10603295034568
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1376-48-000
• Device Catalogue Number: 137648000
• Device Lot Number: J93W29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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: CEMENTRALIZER 10.0MM; MODULAR CATHCART BALL 52MM OD; SUMMIT CEMENTED STEM SZ5 STD; TAPERED SPACER ARTICUL/EZE +0
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male