MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121703054

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Tissue Damage (2104); Injury (2348); Joint Disorder (2373); Inadequate Osseointegration (2646)

Event Date 04/16/2010

Event Type  Injury  

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

New unity record created in order to update legacy complaint number (b)(4).Litigation alleges that patient experienced hip pain, causing difficulty ambulating and sleeping.Additionally, it is alleged that implant is releasing metal ions into patient's body.Doi: unknown - dor: none reported (right hip) - patient is a resident of (b)(6).Update dec 05, 2017: pfs and medical records received.In addition to what was previously alleged, pfs also alleges injury to the patient.After the review of medical records, it was stated that the patient was revised to address pain and severe bone loss.Revision notes reported missing short rotators, some metal staining, very little rotators and posterior capsule, a little area on the neck where there is impingement with cup and small notching, grossly loose cup, deficient acetabular bone.Added product and lot numbers.Added cup and cement product information for the reported loosening.This complaint was updated on: december 20, 2017.Doi: (b)(6) 2004 dor: (b)(6) 2010 (right hip).

Manufacturer Narrative

Udi: (b)(4).

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.

• Brand Name: PINNACLE 300 ACET CUP 54MM
• 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 drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 7159861
• MDR Text Key: 96318353
• Report Number: 1818910-2018-50078
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295008668
• UDI-Public: 10603295008668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

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: Health Professional
• Device Expiration Date: 09/22/2008
• Device Catalogue Number: 121703054
• Device Lot Number: X38EW1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/16/2018; 11/29/2019
• Supplement Dates FDA Received: 12/23/2018; 12/24/2019
• Date Device Manufactured: 09/22/2003
• 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: 69 YR
• Patient Weight: 97