MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-056

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Date 09/23/2020

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 that the liner was either never full engaged with cup or became disassociated from cup.The ceramic femoral head then became in contact with the inner diameter of the acetabular shell.With the ceramic head articulating with the inner diameter of the shell, the shell became compromised causing metallosis and the ceramic head eventually wearing/cutting through the acetabular shell.It is not certain that the liner became disassociated or was improperly placed as there was an unseated screw that was removed.Also, the liner was severely compromised.Doi: (b)(6) 2017, dor: (b)(6) 2020, affected side: unknown.

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: PINN SECTOR W/GRIPTION 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10653518
• MDR Text Key: 210576715
• Report Number: 1818910-2020-21834
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010326
• UDI-Public: 10603295010326
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-32-056
• Device Catalogue Number: 121732056
• Device Lot Number: HF9409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX56OD; DELTA CER HEAD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 56MM; ALTRX NEUT 36IDX56OD; DELTA CER HEAD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 56MM
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR