MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN BANTAM W/GRIPTION 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121730044

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Joint Disorder (2373)

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

Dr (b)(6) hospital.Primary: (b)(6) 2015.Revision to be scheduled.X-ray images indicate disassociation.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Changed from a malfunction to serious injury as revision has occurred.

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned device finds nothing outward to suggest product error.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN BANTAM W/GRIPTION 44MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7295689
• MDR Text Key: 100941212
• Report Number: 1818910-2018-54048
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009948
• UDI-Public: 10603295009948
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121730044
• Device Lot Number: 598932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1