MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887458

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Weakness (2145); Depression (2361); Confusion/ Disorientation (2553); Test Result (2695); Fibrosis (3167); Not Applicable (3189); No Code Available (3191)

Event Date 08/25/2017

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

Pfs and medical records received.Pfs alleges continuous and persistent pain, fatigue, sleep disturbance, affecting thought process, depression and impaired activities of daily living.After review of medical records for mdr reportability, it was stated that the patient was revised to address pain due to implant failure.Revision notes stated that there was a turbid fluid consistent with metallosis, tremendous amount of scar tissue and arthrofibrosis.Clinic visit stated that mri of the hip and pelvis demonstrate some relatively small fluid collection around the greater trochanter and there is trace hip effusion.Cobalt ion level is above 7 ppb.Doi: (b)(6) 2010; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT40IDX58OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7376850
• MDR Text Key: 103662200
• Report Number: 1818910-2018-56237
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2018

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: 02/10/2015
• Device Catalogue Number: 121887458
• Device Lot Number: 3077796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 04/09/2018; 08/20/2018
• Supplement Dates FDA Received: 04/11/2018; 08/27/2018
• Date Device Manufactured: 02/17/2010
• 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: 73 YR
• Patient Weight: 93