MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-056

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/27/2020

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 according to the surgeon, patient experienced pinnacle liner dissociation, as evidenced on x-ray.This finding was confirmed intra-op.Multiple ard tabs were broken off of the liner.The surgeon elected to keep the pinnacle shell, replacing the liner and femoral head.Doi: (b)(6) 2003; dor: (b)(6) 2020; right side.

Event Description

Additional information received stated that the patient received a primary right tha to treat osteoarthritis of the hip.The surgeon noted that the natural interior-anterior acetabular wall was deficient, requiring cup placement in 40-45 degrees abduction and 25-30 degrees anteversion.The procedure was completed without complications.The patient received a pinnacle cup with apex hole eliminator, marathon polyethylene liner, articuleze femoral head, and summit stem.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The provided x-ray images were able to confirm the reported disassociation event.The root cause could not be determined.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: PINNACLE 100 ACET CUP 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: 10252004
• MDR Text Key: 198154222
• Report Number: 1818910-2020-15412
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008576
• UDI-Public: 10603295008576
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 06/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-01-056
• Device Catalogue Number: 121701056
• Device Lot Number: XA8G21015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIMINATOR; ARTICUL/EZE BALL 28 +5 BR; PINN MAR NEUT 28IDX56OD; SUMMIT POR TAPER SZ4 STD OFF; APEX HOLE ELIMINATOR; ARTICUL/EZE BALL 28 +5 BR; PINN MAR NEUT 28IDX56OD; SUMMIT POR TAPER SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR