MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Foreign Body Reaction (1868); Unspecified Infection (1930); No Code Available (3191)

Event Date 05/12/2020

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

Revision case of an infected corail pinnacle.In speaking with the surgeon before the revision procedure, he advised that the patient had primary thr in february this year and has presented to ed with a dissociated acetabular liner and infected hip.Surgeon unable to say why he thought the patient had a dissociated liner but did mention the patient reporting a fall at some stage.Revised hip to zb-g7 dual mobility cup and c-stem (attachment included with product usage from revision case completed today).Revision surgery went as planned.Explanted products not available as retained by hospital.No further information available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: DELTA CER HEAD 12/14 32MM +1
• 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: 10088047
• MDR Text Key: 192023046
• Report Number: 1818910-2020-12544
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1365-32-310
• Device Catalogue Number: 136532310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 LAT COXA VARA SIZE 12; PINN MAR NEUT 50ODX32ID; PINN SECTOR W/GRIPTION 50MM; CORAIL2 LAT COXA VARA SIZE 12; PINN MAR NEUT 50ODX32ID; PINN SECTOR W/GRIPTION 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR