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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 03/04/2019
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.
 
Event Description
"literature article entitled "a minimum of 15-year results of cementless total hip arthroplasty using a 28-mm metal-on-metal articulation" written by chan-woo park, md, joo-hwan kim, md, seung-jae lim, md, young-wan moon, md, youn-soo park, md published by the journal of arthroplasty published online/accepted by publisher 4 mar 2020 was reviewed. The purpose of this study was to evaluate the clinical and radiographic outcomes of the previously reported cohort at a minimum follow-up of 15 years. The original cohort consisted of 171 primary thas (167 patients) using a 28-mm mom articulation performed between april 2000 and march 2002. Of these, 130 hips (126 patients) were reviewed at an average follow-up of 17. 1 (range, 15-18) years. Clinical score, complications, presence of osteolytic lesion, serum metal ion concentrations, and implant survivorships were evaluated. X-ray images can be found on page 3 of article. It is noted 25 deaths occurred that were initially involved in the study, however, there is no indication or allegation a depuy product was the cause or contributed to any of the indicated deaths. The reason for the deaths is not indicated in the study. Depuy products: ultima cementless cup, s-rom cementless stem, unnamed metal-on-metal head and liner, and s-rom sleeve. There is no indication of any revision involving the s-rom sleeve. Adverse events: 9 patients are identified by age and gender. 8 of the 9 underwent revision operations. The ninth patient has not undergone a revision operation. Case 1: male. (b)(6) years old. Revision to address infection and edema. Within one year post-primary. Cup, liner, head, and stem revised. Case 2: female. (b)(6) years old. Revision to address dislocation, groin pain, osteolysis, necrosis, and alval. Cup, liner, and head revised. Case 3: male. (b)(6) years old. Revision due to joint infection and edema. Cup, liner, head, and stem revised 2+ years after primary. Case 4: female. (b)(6) years old. Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval. Cup, liner, and head revised. Case 5: female. (b)(6) years old. Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval. Cup, liner, and head revised. Case 6: male. (b)(6) years old. Revision due to groin pain, osteolysis, elevated metal levels, necrosis, and alval. Cup, liner, and head revised. Case 7: female. (b)(6) years old. Revision due to groin pain, osteolysis, elevated metal levels, and alval. Cup, liner, and head revised. Case 8: male. (b)(6) years old. Revision due to aseptic stem loosening and necrosis. Stem and head revised. Case 9: male. (b)(6) years old. X-ray imaging revealed osteolysis. No revision. ".
 
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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 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11109399
MDR Text Key226057718
Report Number1818910-2021-00015
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeKS
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 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received03/17/2021
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: 01/04/2021 Patient Sequence Number: 1
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