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

Model Number	5460-16-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
Secondary to follow-up information received, this product is no longer considered a serious injury at this time.
Additional 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.
Additional 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
• Common Device Name: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9363243
• Report Number: 1818910-2019-117611
• Device Sequence Number: 19641175
• Product Code: JDK
• UDI-Device Identifier: 10603295174356
• UDI-Public: 10603295174356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/28/2019

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
• Operator of Device: Health Professional
• Device Model Number: 5460-16-000
• Device Catalogue Number: 546016000
• Device Lot Number: D1DVL4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/22/2019; 12/11/2019; 01/20/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 11/28/2019; 12/19/2019; 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR