MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962711000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/12/2021

Event Type  Injury  

Event Description

This pc is related to pc (b)(4) which reports about the revision surgery will be performed due to the head coming off.This pc reports about the primary surgery.It was reported that on unknown date, the patient underwent the primary surgery.After the primary surgery, on (b)(6) 2021, it was found that recurrent dislocation had occurred.No further information is available.Doi: (b)(6) 2008.

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: 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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: 9/10 ULTAMET 36MM HEADS +0
• Type of Device: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12915553
• MDR Text Key: 281590786
• Report Number: 1818910-2021-26864
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2012
• Device Catalogue Number: 962711000
• Device Lot Number: 2448237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 36MM HEADS +0.; UNK HIP ACETABULAR LINER.
• Patient Outcome(s): Required Intervention