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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Loss of Osseointegration (2408)
Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 01/01/2018
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 article entitled, "influence of the type of hip-component fixation and age of patients on mid-term revision rate of total hip replacement" written by v.Kubinec published by acta chir orthop traumatol cech.85, 2018 was reviewed.The article's purpose was to compare different brands and different brand platforms of stems and cups to compare survival rate with specific focus on analyzing the impact of implant type and component fixation technique (cemented vs.Uncemented) correlated with patient age.It is noted that multiple depuy products are listed among non-depuy products.The article reports that all implants within the study required revision for loosening for either or both the femoral stem or acetabular cup.The cement manufacturer is not identified for the cemented implants.The article provides no information regarding reported patient experience.The article does not discuss bearing surfaces of if screws were utilized and focuses on loose cups and loose stems for survivorship.Figure 1 and 2 provide photographic illustration of the different femoral stems (cemented vs non cemented).Figure 3 provides radiographic imaging for a (b)(6) year old female patient with cemented charnley stem that loosed 3 years post implantation followed by a periprosthetic fracture.The other radiographic figures portray non-depuy products as described in figure narrative description.Depuy products: ultima cemented stem, charnley monoblock/modular cemented stem, mecroblock mr uncemented stem, aml uncemented stem, ultima threaded cups (uncemented), duraloc cup (uncemented), ultima uhmwpe cup (cemented all poly) elite plus cups (cemented all poly).Adverse events: loose stems (treated by revision).Loose cups (treated by revision).Figure 3 cemented loose charnley stem for 64 year old female (treated by revision).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
 
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Brand Name
UNKNOWN HIP FEMORAL STEM
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10001670
MDR Text Key190311317
Report Number1818910-2020-11352
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/20/2020
Initial Date FDA Received04/27/2020
Supplement Dates Manufacturer Received05/05/2020
Supplement Dates FDA Received05/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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