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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the patient's left hip was revised due to infection.All components were removed and a cement spacer was placed.The patient's original total hip was done (b)(6) 2020 and he had an i&d washout, head liner exchange, on (b)(6) 2020.Doi: (b)(6) 2020; dor: (b)(6) 2021; affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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
• MDR Report Key: 11672343
• MDR Text Key: 245607613
• Report Number: 1818910-2021-08032
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 10603295034568
• UDI-Public: 10603295034568
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• 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: J4732A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX52OD; CEMENTRALIZER 10.0MM; DLT TS CER HD 12/14 36MM +5.0; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 52MM; SUMMIT CEMENTED STEM SZ5 STD; ALTRX NEUT 36IDX52OD; CEMENTRALIZER 10.0MM; DLT TS CER HD 12/14 36MM +5.0; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 52MM; SUMMIT CEMENTED STEM SZ5 STD
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR