MAUDE Adverse Event Report: J AND J DEPUY PINNACLE SECTOR II ACETABULAR CUP

Catalog Number 1217-22-050

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/24/2014

Event Type  Injury  

Event Description

Fifth dislocation - right hip.

• Brand Name: PINNACLE SECTOR II ACETABULAR CUP
• Type of Device: PINNACLE
• Manufacturer (Section D): J AND J DEPUY
• MDR Report Key: 6871665
• MDR Text Key: 86602570
• Report Number: MW5072167
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

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: No Information
• Device Catalogue Number: 1217-22-050
• Device Lot Number: ZF2CD1000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization