MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-320

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 04/30/2020

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

It was reported as per surgeon, patient dislocating.The patient has a competitor cup and converting to a longer head and dual mobility.Current distal stem 1976-21-140 l-j1362w.Doi: (b)(6) 2018.Dor: (b)(6) 2020.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.

• Brand Name: DELTA CER HEAD 12/14 36MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10052750
• MDR Text Key: 190822929
• Report Number: 1818910-2020-12045
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033622
• UDI-Public: 10603295033622
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-36-320
• Device Catalogue Number: 136536320
• Device Lot Number: 8955335
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 36MM +5; RECLAIM DISTAL TAPERED 21X140; UNKNOWN HIP ACETABULAR LINERS; DELTA CER HEAD 12/14 36MM +5; RECLAIM DISTAL TAPERED 21X140; UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 110