MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX52OD; HIP POLY ACETABULAR LINERS

Catalog Number 122132152

Device Problems Disassembly (1168); Fracture (1260); Material Separation (1562); Metal Shedding Debris (1804); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Scarring (2061); Tissue Damage (2104); Injury (2348); Joint Dislocation (2374)

Event Date 07/28/2017

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

Claim letter alleges that the patient sustained injuries related to the pinnacle hip replacement.Doe: (b)(6) 2017 (unknown hip).

Event Description

Claim letter and medical records received.In addition to what was previously alleged, claim letter alleges pain, popping and squeaking noise, fractured left hip liner, dislocation, implant wear, spotty black discoloration on the removed implants and scarring due to the revision.After the review of medical records, patient was revised to address dissociation and accelerated wear of ceramic femoral head.Revision notes reported black-type corrosive fluid, corroded head, wearing on the liner, oxidative black tissue and cup disassociated after removing the femoral implant.X-ray reported of abnormal liner fractured and abnormal wear.Clinical visits reported of clicking hip, eccentric placement of femoral head and hip injury.Surgical pathology reported of shiny black discoloration and fragment from acetabular component.

Manufacturer Narrative

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

Corrected data g7: this correction is being submitted to correct the sequential numbering for the follow up report #2.Follow up #1 submitted on (b)(6) 2017 should have been submitted as follow up #1.Follow up #3 submitted on (b)(6) 2017 should have been submitted as follow up #2.Follow up #4 submitted on (b)(6) 2017 should have been submitted as follow up #3.Follow up #5 submitted on (b)(6) 2017 should have been submitted as follow up #4.Although it appears there are gaps in the sequential follow-up numbers, there are no missing reports.

• Brand Name: ALTRX +4 10D 32IDX52OD
• Type of Device: HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 7291711
• MDR Text Key: 100763291
• Report Number: 1818910-2018-53955
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016175
• UDI-Public: 10603295016175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 122132152
• Device Lot Number: 409850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2018
• Date Device Manufactured: 08/06/2013
• 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: 46 YR
• Patient Sex: Female