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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL AUGMENT
Device Problem Loss of Osseointegration (2408)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Skin Irritation (2076); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 05/02/2019
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, "declining revision burden of metal-on-metal hip arthroplasties" written by olli s. Lainiala, md, phd, aleksi p. Reito, md, phd, jyrki j. Nieminen, md, phd, and antti p. Eskelinen, md, phd published by the journal of arthroplasty made available online on 2 may 2019 was reviewed. The article's purpose was to report the survivorship for various stemmed metal on metal total hip arthroplasties and hip resurfacings for both primary and revision surgeries in one of the world's largest single-institution mom hip arthroplasty cohorts and to describe the reasons and temporal trends for revisions and to analyze risk factors for revisions. It is noted that depuy products were listed in the data set with other non-depuy products. Cement manufacturer is not identified for resurfacings. The article provides a list of indications for revision but does not clarify which specific products are associated with each type of revision reason. Therefore, accurate quantities cannot be determined in this complaint based upon the limited information provided by the article. Depuy products: asr head, asr cup, asr xl head, asr xl cup, asr xl sleeve (augment), pinnacle cup, metal liner, metal head, srom stem, srom sleeve (augment). Revision reasons: armd attributed to bearing wear, infection, femoral periprosthetic fracture and femoral neck fracture and trochanteric fracture, femoral loosening, acetabular loosening, "loosening of mom liner", multiple dislocations/instability, impingement, acetabular fracture, osteolysis of femoral neck, malposition of cup component, acetabular osteolysis, unexplained pain, rash.
 
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Brand NameUNKNOWN HIP FEMORAL AUGMENT
Type of DeviceHIP FEMORAL AUGMENT
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 Key10313860
MDR Text Key200446845
Report Number1818910-2020-16655
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 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
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 Received08/04/2020
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: 07/23/2020 Patient Sequence Number: 1
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