MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 56MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722056

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Tissue Damage (2104); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pinnacle litigation received. Litigation alleges defective implant resulting to damage to patient¿s hip joint and body, pain and emotional distress. Doi: (b)(6) 2006; dor: not reported; 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges loosening of stem, metal wear, metallosis, and elevated metal ions.

• Brand Name: PINNACLE SECTOR II CUP 56MM
• 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, IN 19380-0988 ; 6103142063
• MDR Report Key: 7595680
• MDR Text Key: 110912489
• Report Number: 1818910-2018-61994
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 121722056
• Device Lot Number: A5EHM1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/27/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/13/2018 Patient Sequence Number: 1