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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Thrombosis (2100); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Date 06/29/2011

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, ¿fixation failures of dual mobility cups: a mid-term study of 2601 hip replacements¿ by philippe massin, md, phd, et al, published by clinical orthopaedic related research (2012), vol.470, pp.1932-1940, was reviewed.The purpose of this article was to determine the midterm survival of press-fit, grit-blasted, second-generation cups with or without additional screws, compared with original tripod and to compare the survival of grit-blasted dual-mobility cups with bimetallic porous-coated cups.The authors reviewed 2408 patients with osteoarthritis implanted with 2601 prostheses of seven designs of a second-generation dual mobility cup implanted between 1998-2003.This article compares dual mobility cups manufactured by depuy and competitors.Implanted depuy products: of the 2601 studied dual mobility cups, 590 were gyros dual mobility cups secured with acetabular screws paired with a polyethylene liner and depuy ceramic or metal femoral heads.The manufacturer of the stems used in all cases was unknown.Results: the results provided by the authors are for all 2601 dual mobility cups.There is insufficient information to determine how many gyros dual mobility cups were associated with the following results.21 total symptomatic deep vein thrombi- treatment was non-surgical 279 leg length discrepancies greater than 1 cm-non-surgical treatment unspecified 24 deep infections treated with revision 3 cases acetabular osteolysis treated with revision 14 dislocations- 10 treated with closed reduction and 4 treated with revision 53 hematomas treated surgically 5 regressive sciatic nerve palsies- no treatment specified 76 cases of psoas impingement associated with pain and difficulty walking- 75 required no surgical treatment and one was treated with revision 31 periprosthetic acetabular fractures treated with revision 10 migrated cups- no treatment required 23 loosened cups treated with revision 13 symptomatic pulmonary embolisms 3 cerebrovascular accidents- the authors note the cvas were life threatening but treatment was unspecified the authors note two deaths not attributed to the surgical procedure or implanted products.These two deaths are not included in this complaint.Captured in this complaint: gyros cup: implant loosening, implant migration.Acetabular screw: implant loosening, implant migration.Polyethylene liner: implant dislocation.Femoral head: implant dislocation.Patient harms: pain, surgical intervention, medical device removal, infection, joint dislocation, nerve injury, walking difficulty, inadequate osseointegration, limb asymmetry, fracture, hematoma, dvt, pe, cva.It is unknown how many of the adverse events were associated with depuy products.".

• 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: 9376597
• MDR Text Key: 185041629
• Report Number: 1818910-2019-116221
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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: 11/06/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention