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 Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Irritation (2076); No Code Available (3191)

Event Date 06/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Literature article entitled, ¿lower periprosthetic bone loss and good fixation of an ultrashort stem compared to a conventional stem in uncemented total hip arthroplasty: a randomized clinical trial with dxa and rsa in 51 patients¿ by mats salemyr, et al, published by acta orthopaedica (2015), vol.86, no.6, pp.659-666, was reviewed.The purpose of this study was to determine if an ultra-short uncemented stem would give less periprosthetic bone loss in the proximal femur than a conventional tapered uncemented stem, and if the ultra-short stem would achieve good fixation and be safe to use from a clinical standpoint.The authors compared 26 ultrashort stems with 25 conventional stems implanted between october 2009 and august 2013.The authors used dxa scan and other radiological studies over the course of e 24-month follow-up.Implanted depuy products: proxima ultrashort stems used in conjunction with depuy cups, polyethylene liners, and femoral heads.The products used in the control group were manufactured by a competitor.Results: 1 postoperative periprosthetic femur fracture- treatment unknown 1 gross varus stem migration with associated pain 3 weeks after index surgery.Stem revised to an unknown convention stem.I hip with postoperative ischialgia.Treatment for the sciatic nerve pain was unknown.3 instances of unexplained persistent postoperative pain- no intervention required.2 unspecified skin rashes.Treatment unknown- coded skin reaction 1 case of urticaria- treatment unknown- coded allergic reaction there was an unknown number of ultrashort stems that migrated into varus in the first 3 preoperative months.This migration was less than 2-mm.There was no device migration seen after 3 months and all stems were stable and osseointegrated at final follow-up.The authors note that 1 patient in the ultrashort group died of causes unrelated to the tha.There was one reported case of polymyalgia rheumatica and i case of unspecified malignancy in the control group- these conditions were unrelated to the implanted products and are not included in this complaint.There were no cases of bone loss noted in the study.Captured in this complaint: proxima ultrashort femoral stem for implant migration and postoperative periprosthetic fracture.The stem, cup, head, and liner for allergic reaction, skin reaction, nerve injury, and pain.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9325596
• MDR Text Key: 182634971
• Report Number: 1818910-2019-114383
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention