MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Sepsis (2067); Tachycardia (2095); No Code Available (3191)

Event Date 12/14/2015

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

Literature article received entitled "cementless total hip replacements in sickle cell disease. " literature article entitled "cementless total hip replacements in sickle cell disease" by christopher m. Jack, et al, published by hip (14 december 2015) vol. 26, no. 2, pp186-192, doi: 10. 5301/hipint. 5000317 was reviewed for mdr reportability. This article reviews the perioperative reaction to tha implants of patients who have sickle cell disease (scd). 52 primary thas were carried out in 40 patients: $* s-rom femoral stems, 1 aml femoral stem, and 3 solutions femoral stems; 42 duraloc acetabular cups, 9 pinnacle cups, and 1 delta motion cups; 42 forte on forte acetabular liners and femoral head bearings, 10 delta on delta acetabular liners and femoral heads; and 35 total screws- 7 hips with two screws, 9 hips with no screws, and the remaining hips with one screw. The text of the article does not specify which of the following patient harms applies to which product or device. There were five cased of intraoperative femur fracture during reaming that were treated with cerclage. There were two cases of postoperative dislocation. One was treated with closed reduction and the other was treated with revision, where that patient developed postoperative pseudomonas sepsis. One patient experienced a postoperative ventricular tachycardia (vt) arrest. There were two cases of reported leg lengthening postoperatively due to bone sclerosis preventing adequate femur preparation for the stem. The article discusses the need for patients with scd to receive transfusions because of the nature of their disease process. There were no reported cases of the need for transfusions unrelated to scd or as a result of depuy products or devices. At follow-up, there were no cases of osteolysis with any of the cementless implants. There were no reports of device noise, impingement, inadequate osseointegration, nerve damage, or device fracture. Adverse event(s) related to product(s): unknown acetabular liner (2): implant dislocation: hip. Unknown acetabular head (2): implant dislocation: hip. Patient(s) reported harm(s) prior to procedure: surgical intervention, pain, fracture: intra-op (stem (3) only), sepsis, joint dislocation (cup and liner only), sepsis, tachycardia, limb asymmetry (stem only).

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8908503
• MDR Text Key: 155063528
• Report Number: 1818910-2019-101545
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 08/19/2019 Patient Sequence Number: 1