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 Problems Pain (1994); No Code Available (3191)

Event Date 10/29/2020

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

The patient was revised due to pain.Doi: (b)(6) 2019.Dor: (b)(6) 2020; affected: right 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 per wi-3430, a manufacturing review (mre) is unlikely to add value to the complaint investigation regarding an allegation of pain.Mre not requested.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 10836802
• MDR Text Key: 216142619
• Report Number: 1818910-2020-24570
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 10603295034568
• UDI-Public: 10603295034568
• Combination Product (y/n): N
• PMA/PMN Number: K871510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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: J0808N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 32 +5 BR; PROSTALAC ACET CUP 42X32; PROSTALAC HIGH 105MM STEM SZ1; ARTICUL/EZE BALL 32 +5 BR; PROSTALAC ACET CUP 42X32; PROSTALAC HIGH 105MM STEM SZ1
• Patient Outcome(s): Required Intervention