MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-048

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 patient was revised due to dislocation.There was an indication that the cup may have been in a suboptimal position.In addition, the patient does have spine hardware which may have been a contributing factor.There is no additional information available for this patient.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: 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: PINNACLE SECTOR II CUP 48MM
• 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: 10460595
• MDR Text Key: 204581228
• Report Number: 1818910-2020-18903
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009801
• UDI-Public: 10603295009801
• Combination Product (y/n): N
• PMA/PMN Number: K033273
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-048
• Device Catalogue Number: 121722048
• Device Lot Number: J7264F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX48OD; ARTICUL/EZE BALL 32 +1 GR; PINN CAN BONE SCREW 6.5MMX20 MM; PINN CAN BONE SCREW 6.5MMX30 MM; ALTRX NEUT 32IDX48OD; ARTICUL/EZE BALL 32 +1 GR; PINN CAN BONE SCREW 6.5MMX20 MM; PINN CAN BONE SCREW 6.5MMX30 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 63