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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 Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem 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) 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 (b)(6) female (treated by revision).

 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
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 Key10001675
MDR Text Key189652353
Report Number1818910-2020-11350
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeUS
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,Followup
Report Date 04/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2020
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/27/2020 Patient Sequence Number: 1
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