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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Pulmonary Embolism (1498); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Thrombosis (2100); Tissue Damage (2104); Joint Dislocation (2374); No Code Available (3191)
Event Date 04/14/2020
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
The literature article entitled, "complications and re-revisions after revisions of 528 metal-on-metal hips because of adverse reaction to metal debris" written by olli lainiala, aleksi reito, jyrki nieminen and antti eskelinent published by acta orthopaedica published online on 14 april 2020 was reviewed. The article's purpose is to report reasons for re-revision and complications after revisions of mom (metal on metal) hip due to armd (adverse reaction to metal debris). Data was compiled from 528 mom hips in 466 patients (420 were stemmed and 108 were resurfacings) that were revised for armd. All resurfacing revisions received femoral stems and revision thas retained femoral stems if found well fixed and correctly positioned. Table 2 within supplementary data provides identity of implants utilized in primary included in the data set, and table 3 within supplementary data provides identity of implants utilized in revision in the data set. It is noted that depuy and non-depuy implants are listed within table 2 (primary implants) and table 3 (revision implants). The article reports all resurfacing revisions received a stem and cup implants listed in table 2. Cement manufacturer is not identified for any constructs that were cemented. Femoral stems were not identified but assumed by identified cup manufacturer. Implants were identified by cup manufacturers with information provided on bearing surface materials. The article does not provide any radiographic images for illustrative purposes. Depuy implants utilized in primary: asr femoral head (qty 68), asr cup (qty 68), asr xl femoral head (qty 237), asr xl sleeve (augment qty 237), asr xl cup (qty 237), pinnacle cup (qty 68), pinnacle metal liner (qty 68), metal femoral head, unknown femoral stem. Reasons for revision to primaries: armd. Pseudotumor. Elevated ion levels. Depuy implants utilized in revision: pinnacle cup (35 liners only exchanges occurred during revision), liner (poly or ceramic), femoral head (ceramic or metal), deltamotion cup, sleeve (augment). Adverse events associated with revision implants but not associated with specifically identified revision implants: recurrent dislocation (treated by re-revision and/or closed reduction). Periprosthetic femoral fracture (treated by re-revision). Acetabular fracture (treated by re-revision or non-operative treatment). Fracture of stem component (treated by re-revision). Aseptic loosening of stem (treated by re-revision). Recurrent armd (treated by re-revision). Infection (treated by re-revision). Fascial rupture (treated by re-suture without change of components). Hernia (no indication of treatment). Residual pseudotumor (no indication of treatment). Pulmonary embolism (no indication of treatment). Deep vein thrombosis (no indication of treatment). Bowel occlusion (no indication of treatment).
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10253461
MDR Text Key203673083
Report Number1818910-2020-15452
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received07/14/2020
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: 07/09/2020 Patient Sequence Number: 1
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