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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Test Result (2695); No Code Available (3191)
Event Date 01/01/2019
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, "no added value for computer-assisted surgery to improve femoral component positioning and patient reported outcomes in hip resurfacing arthroplasty; a multi-center randomized controlled trial" written by m. C. Koper, m. Reijman, e. M. Van es, j. H. Waarsing, h. W. J. Koot, s. B. Keizer, i. Janesen, f. C. Van biezen, j. A. N. Verhaar, and p. K. Box published by bmc musculoskeletal disorders in 2019 was reviewed. The article's purpose was to compare femoral component positioning between cas (computer assisted surgery) and manual placement in a multi-center, patient-blinded, randomized controlled trial. All patients received depuy asr implants and the cement manufacturer is not identified. Data was compiled from 125 patients (133 hips) with 67 hips in the manual placement 66 hips in the cas group. The article provides details for the 11 total revisions in table 5 with patient identifiers, and the article reports all revision cases were managed with total hip arthroplasty. Figure 1 provides radiographic images for illustrative purposes and does not indicate any adverse events within caption description. Depuy implants: asr cup, asr femoral head. Early complications and generalized adverse events: one patient with minor cardiac ischemia (no treatment indicated and no further information provided). One patient complained of painful lower leg and swelling but thrombosis was excluded (no treatment indicated and no further information provided). One patient had superficial skin infection (treated with oral antibiotics and resolved without further problems). Revisions in cas group: case 1 - (b)(6) years old female with 46 mm size component revised for collum fracture 3 months post primary and received revision to femoral component. Case 2 - (b)(6) years old male with 49 mm size component revised for collum fracture 25 months post primary and received revision to femoral component. Case 3 - (b)(6) years old male with 53 mm size component revised for armd and high cobalt/chromium 29 months post primary and received revision to femoral and acetabular components. Case 4 - (b)(6) years old female with 47 mm size component revised for aseptic loosening 30 months post primary and received revision to femoral and acetabular components. Case 5 - (b)(6) years old female with 46 mm size component revised for collum fracture 1. 5 months post primary and received revision to femoral component. Revisions in manual placement group: case 6 - (b)(6) years old male with 49 mm size component revised for pain 25 months post primary and received revision to femoral component. Case 7 - (b)(6) years old female with 45 mm size component revised for aseptic loosening 8 months post primary and received revision to femoral and acetabular components. Case 8 - (b)(6) years old female with 43 mm size component revised for aseptic loosening 21 months post primary and received revision to femoral and acetabular components. Case 9 - (b)(6) years old male with 51 mm size component revised for pain and high cobalt/chromium 21 months post primary and received revision to femoral and acetabular components. Case 10 - (b)(6) years old female with 41 mm size component revised for altr and high cobalt/chromium 22 months post primary and received revision to femoral and acetabular components. Case 11 - (b)(6) years old male with 51 mm size component revised for aseptic loosening. 5 months post primary and received revision to acetabular component.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD - 8010379
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10273370
MDR Text Key200791882
Report Number1818910-2020-15849
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 07/14/2020 Patient Sequence Number: 1
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