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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Pulmonary Embolism (1498); Bone Fracture(s) (1870); Pain (1994); Thrombosis (2100); Joint Dislocation (2374); Osteolysis (2377); Impaired Healing (2378); Inadequate Osseointegration (2646)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: 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. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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, ¿cemented charnley revision arthroplasty for severe femoral osteolysis¿ by v. V. Raut, et al, published by the journal of bone and joint surgery (1995), vol. 77-b, pp. 362-365, was reviewed for mdr reportability. The authors reviewed prospectively cemented stem revision in 106 patients with severe femoral endosteal bone lysis without infection implanted with the charnley tha from 1997-1990. Femoral heads are unspecified. Results: charnley became a depuy product in 1990. This complaint captures all reported complications and revisions from 1977-1990 because the authors do not specify when the complications occurred. 10 femur fractures, 5 stem migrations requiring revision, 13 cup and head revisions due to loosening and osteolysis, 7 re-revisions of stem and cup for loosening (6), femur fracture (1), and unexplained pain (1), 17 cases of osteolysis of the acetabulum and femur. Complications: 3 calcar fractures intraoperatively, 1 femur perforation intraoperatively, 2 trochanter fractures, 3 dislocations, 10 non-union of the trochanters requiring revision, 4 pulmonary emboli, 3 unspecified abdominal complications, 3 unspecified cardiovascular complications, 3 deep vein thrombi, 2 delayed wound healing. It is unknown how many of these complications and revisions are attributed to depuy products. The article does not provide enough information to identify time of each occurrence. Additionally, the authors do not provide the manufacturer of the bone cement or restrictor used. This complaint captures all complications and interventions. The abdominal and cardiovascular complications are unspecified. There is not enough information to include these within the complaint. ".
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP 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 Key9213826
MDR Text Key176331331
Report Number1818910-2019-110915
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK 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 Received09/27/2019
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
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