MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Disassembly (1168); Fracture (1260); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The initial report would have been submitted on 18-jan-2018 with a due date of 18-jan-2018.Due to an issue with the fda esg or cdrh emdr processing system on 18-jan-2018, the report was not received in a timely manner.

Event Description

Literature article received: "the incidence of dissociated liners in 4,751 consecutive total hip arthroplasties using pinnacle polyethylene acetabular liners" eight separate polyethylene liner disassociations were identified, and each is reported separately for purposes of product complaint capture.This is patient 2, female, (b)(6) at primary surgery, and (b)(6) at revision for liner dissociation (60 months after primary).Reported liner-cup dissociation of a depuy enduron 28mm id liner and pinnacle cup, with implant fracture of 4 of the 6 liner ards.There was wear deformity of the liner (ovoid shape), as well as metallosis identified, but minimal damage to the cup.There was an additional liner-cup dissociation following the revision at 22 months post first revision surgery.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7205876
• MDR Text Key: 97750886
• Report Number: 1818910-2018-51544
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• 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: 79 YR