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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Nonstandard Device (1420); Loss of Osseointegration (2408); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Skin Irritation (2076); Joint Dislocation (2374); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 05/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. 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 ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10313797
MDR Text Key200443816
Report Number1818910-2020-16648
Device Sequence Number1
Product Code KWA
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
Remedial Action Recall
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 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 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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 07/23/2020 Patient Sequence Number: 1
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