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

Catalog Number 121701056

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 08/31/2016

Event Type  Injury  

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.Initial reporter occupation: lawyer.(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

In addition to what were previously alleged, ppf alleges recurrent dislocation.After review of medical records, added code malposition to cup since previous operative notes mentioned that the cup was 25-25 degrees anteverted on revision (b)(6) 2016 and (b)(6)2016.Added medical history.Doi: (b)(6) 2004 (cup and hole eliminator).Doi: (b)(6) 2016 (head and liner).Dor: (b)(6) 2016 (right hip).

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9519682
• MDR Text Key: 185192839
• Report Number: 1818910-2019-124624
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008576
• UDI-Public: 10603295008576
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121701056
• Device Lot Number: YY5E31000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2004
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR