MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-310

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Joint Dislocation (2374); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received.On (b)(6) 2010 patient was revised due to instability.Prior to revision patient had clicking, recurrent dislocation and swelling.Sharp dissection in the tensor fascia was made and gluteus was split in line with its fibers.Cup was solid and well placed but secondary to instability, it was necessary to remove the cup with minimal bone loss.Doi: (b)(6) 2009, dor: (b)(6) 2010, right hip 2nd revision.

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

• Brand Name: DELTA CER HEAD 12/14 36MM +1.5
• 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: 12437185
• MDR Text Key: 270275300
• Report Number: 1818910-2021-19533
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 1365-36-310
• Device Catalogue Number: 136536310
• Device Lot Number: 3006011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; UNKNOWN HIP FEMORAL STEM; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR