MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 DLT TS CER HD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536710

Device Problems Biocompatibility (2886); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Test Result (2695)

Event Date 11/10/2017

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.Occupation: lawyer.

Event Description

Ppf alleges dislocation and elevated metal ions after first revision.

Manufacturer Narrative

This is a duplicate report of 1818910-2017-51101.1818910-2019-93126 is being retracted as it is a report duplication.1818910-2017-51101 will be kept for investigation purposes.

• Brand Name: DLT TS CER HD 12/14 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8599339
• MDR Text Key: 144688476
• Report Number: 1818910-2019-93126
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033653
• UDI-Public: 10603295033653
• Combination Product (y/n): N
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136536710
• Device Lot Number: 3437342
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR