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

Catalog Number UNK HIP ACETABULAR LINER

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/29/2015

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. (b)(4).

Event Description

"literature article entitled, ¿prosthetic hip infection with edwardsiella tarda in sickle cell beta thalassemia disease: a case report¿ by david b. Frumberg, md, et al, published by journal of clinical orthopaedics and trauma (2016), vol. 7s, pp. 130-133, was reviewed for mdr reportability. The authors report a previously unrecognized gram-negative bacillus as the infecting agent in a patient with bilateral total hip arthroplasties for stage iv osteonecrosis. A 23-year-old male with combined sickle cell disease and beta thalassemia with a prior history of unknown hip surgeries and treatment for distal tibial osteomyelitis in africa developed a periprosthetic joint infection; intra-operative cultures confirmed the infecting organism to be edwardsiella tarda which was sensitive to late-generation cephalosporins and vancomycin. He was successfully treated with a staged revision total hip arthroplasty with an antibiotic spacer and has been infection-free since. The patient he underwent a right tha with a cementless modular stem, ceramic-on-ceramic bearing, and cementless cup (s-rom modular implant with a duraloc acetabular cup, depuy). During seating of the metaphyseal sleeve, an incomplete calcar fracture at the level of the lesser trochanter was discovered and fixed with two cerclage cables. Perioperative course was otherwise uneventful. Two months post-operatively, he had a sickle cell crisis which was conservatively managed. At his four-month postoperative clinic visit, a superficial wound dehiscence was observed which was treated aggressively with 1 week of iv vancomycin and oral amoxicillin. His dehiscence closed but an area of subcutaneous abscess emerged, from which purulent material was aspirated. He was indicated for surgical exploration and debridement of the wound. During surgery, purulent drainage was noted from a sinus in the fascia lata, but the short external rotators and hip joint capsule were intact. Intraoperative cultures were negative. Per infectious disease recommendations, he was discharged on a two-week course of oral amoxicillin/clavulanic acid. After 4 weeks, he reported increased pain and wound drainage and was indicated for irrigation and debridement. During surgery, the fascial sinus was observed to communicate with the hip joint. The acetabular component was well fixed, but the femoral component was loose. The stem and sleeve were removed and an antibiotic cement spacer with 6gm of vancomycin and 7. 2gm of tobramycin was placed (competitor product). After 3 weeks of aggressive antibiotic treatment, he was then indicated for second-stage reimplantation. He underwent irrigation and debridement, removal of cement spacer, and revision tha with a cementless modular femoral stem, ceramic-on-polyethylene bearing, and a cementless acetabular component (competitor products). The acetabular components and femoral head were explanted due to infection. There was no reported product problem with the components. The authors note that patients who have sickle cell crisis and iron overload are highly susceptible to the infectious organism e. Tarda. They further note that this was the first known, reported case of e. Tarda periprosthetic infection. Captured in this complaint: s-rom stem and sleeve for implant loosening and infection, duraloc cup and locking ring, ceramic head, and ceramic liner for infection. The femoral head and acetabular components had no reported product deficiencies. During the index tha, the patient had no discernable femoral canal and the surgeons had to perform extensive reaming to insert the stem and sleeve causing the intraoperative calcar fracture. ".

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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: 9216676
• MDR Text Key: 176337790
• Report Number: 1818910-2019-109511
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR LINER
• 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: 11/12/2019
• 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: 10/21/2019 Patient Sequence Number: 1