MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 HA ACET CUP 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121711058

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2013

Event Type  Malfunction  

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

Complaint description from etq: 1217-11-058 x1 pinnacle acetabular shell 100 series (lot: 311131) was implanted as per surgical technique. Subsequently, surgeon attempted to screw in (1246-03-000) apex hole eliminator (lot: d13033399) into acetabular shell. However, the apex hole eliminator could not screw into threads of acetabular shell. Therefore, a second apex hole eliminator (lot: d13050493) was opened. This too could not be implanted. The surgeon then said, although he had never had this issue in his multiple prior cases, the threads of the acetabular shell must have been burred. The surgeon decided to not worry about using a hole eliminator and subsequently implanted a shell liner, as per surgical technique. The operation was completed with no further problems.

• Brand Name: PINNACLE 100 HA ACET CUP 58MM
• 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: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8746153
• MDR Text Key: 173644850
• Report Number: 1818910-2019-97197
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (Y/N): N
• Reporter Country Code: AS
• PMA/PMN Number: K031495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/28/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 121711058
• Device LOT Number: 311131
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/07/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial