MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENT RESTRICTOR SIZE 4; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number 5460-16-000

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

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 11/21/2019

Event Type  Injury  

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.

Event Description

The primary surgery was performed on (b)(6) 2009 via tha.The patient complained of a pain and it was performed arthrocentesis however there was no abnormality in joint fluid etc.And there was no swelling.It was reported that the revision surgery was scheduled to be performed on (b)(6) 2019 by replacing the stem (p/n: 961174000), the end cap (p/n: 961226000), the centralizer (p/n: 961246000), the cement restrictor (p/n: 546016000), the head (p/n: 962711000),the liner (p/n: 121887354), the cup (manufactured by (b)(4), p/n: 121780054, lot#: 00797) with 3 screws (manufactured by (b)(4), p/n's: 556070j, lot#s: 02327, 02241, 02239) because he still had an intense pain.No further information is available.

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.

Event Description

Secondary to follow-up information received, this product is no longer considered a serious injury at this time.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.Product complaint # (b)(4).Investigation summary : the stem was returned for investigation and the complainants findings confirmed, the stem had fractured in the lower section of the stem.Device history lot : null.Device history batch : null.Device history review : null.

• Brand Name: CEMENT RESTRICTOR SIZE 4
• 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: 9363243
• MDR Text Key: 185073897
• Report Number: 1818910-2019-117611
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 10603295174356
• UDI-Public: 10603295174356
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5460-16-000
• Device Catalogue Number: 546016000
• Device Lot Number: D1DVL4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR