MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/21/2013

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.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).

Event Description

"literature abstract entitled, ¿increase of cortical bone after a cementless long stem in periprosthetic fractures¿ by eduardo garcia-rey md, phd, ebot, et al, published by clinical orthopaedic related research (2013), vol.471, pp.3912-3921, was reviewed.This study is part of a long-term review of a single study cohort of patients who had tha revision surgeries between 1992-2006.The patients in this cohort began the study with revisions of tha components due to aseptic loosening of one or both in bone components.The original components were manufactured by depuy and competitors.This complaint will capture the results reported on this cohort in this article, mirf-000100510 article entitled, ¿stress-shielding of the proximal femur using extensively porous-coated femoral component without allograft in revision surgery¿, and mirf-000101597 article entitled, ¿the survival and fate of acetabular reconstruction with impaction grafting for large defects¿.The primary focus of this long-term study was solution stem used in the index revision surgery.The charnley tha was the only depuy product in the initial revision surgery.Implanted depuy products: there were 32 charnley thas in this cohort including a cemented polyethylene cup, an unknown femoral head, and either a cemented or cementless charnley stem.114 cementless solution stems were used in femoral revision surgery.The cement used in the charnley tha was a competitor product.Results: 40 intraoperative femoral fractures treated with cerclage wiring.2 femoral perforations during reaming.1 required no treatment and 1 was treated with an unknown plate and screws.1 deep infection treated with revision of all components.3 cases of hematoma treated with anticoagulant therapy.2 stem revisions due to pain, stem loosening, and stem migration secondary to femoral osteolysis.In one of these cases, intraoperative findings revealed the stem fit was too small.15 cases of limp causing permanent walking difficulty requiring the use of mobility aids- coded walking difficulty.11 revisions of charnley cups due to aseptic loosening.There was insufficient information provided to attribute the loosening to the cup that was cemented with competitor cement.Intraoperative findings revealed significant acetabular bone resorption in all 11 cases.There was an unknown number of intraoperative and radiographically identified mispositioned cups.2 dislocations treated with closed reduction.2 dislocations treated with revision of the cups and heads.7 cases of limb asymmetry greater than 2-cm.6 cases of radiographically identified non-progressive stem subsidence.It is unknown if these stems were treated with revision surgery for other reasons.29 cases of femoral bone loss.It is unknown if these stems were treated with revision surgery for other reasons.Captured in this complaint: hip instrument: reamer; no reported product problem, fracture intra-op.Charnley polyethylene cup: implant dislocation, implant mispositioned, osteolysis, medical device site erosion, joint dislocation.Femoral head: implant dislocation, joint dislocation, limb asymmetry.Femoral stem: implant loosening, implant fit/too loose, implant migration, pain, fracture, limb asymmetry, inadequate osseointegration, medical device site erosion.Patient harms: walking difficulty, surgical intervention, medical device removal.The reported pain was attributed to the femoral stem loosening secondary to osteolysis.The events listed applied to depuy products.".

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9425185
• MDR Text Key: 185215723
• Report Number: 1818910-2019-121356
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2019
• 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