Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191); Physical Asymmetry (4573)
Event Date 06/19/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address loosening of the cup at the bone to implant interface.It was also reported that the cup, head and sleeve were removed.Doi: unknown; dor: (b)(6) 2018; left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a4, b5, b7, h4 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d6a and h6 (device code).
 
Event Description
After review of the medical records and in addition to what was previously reported the patient was revised due leg length discrepancy, limited mobility/adl, cup disassociated from the femoral head, stem had some varus alignment.Operative note reported there is a fair amount of bursal tissue and was debrided, abductor and iliotibial attachment is thin, stained synovitis was also debrided.It was also noted that there was a worn portion of the superior roof of the cup, cup was loose and displaced.Also worn in the medical wall, osteolysis along the acetabulum.Clinical visit reported dislodgement of the cup and head and had soft tissue reaction.Doi: (b)(6), 2006 ; dor: (b)(6), 2018; left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Update 9-jun-2021: the investigation was re-opened upon receipt of additional information.The new information does not affect the existing investigation.Device history lot: a worldwide product / lot specific complaint database search, or device history record (dhr) review, was not possible because the required product/lot code(s) was not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10508302
MDR Text Key206156476
Report Number1818910-2020-19645
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup
Report Date 08/25/2020
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? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/25/2020
Initial Date FDA Received09/09/2020
Supplement Dates Manufacturer Received09/30/2020
03/10/2021
06/09/2021
Supplement Dates FDA Received10/01/2020
03/23/2021
06/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADAPTER SLEEVE 11/13 +3; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; UNKNOWN HIP FEMORAL STEM; ADAPTER SLEEVE 11/13 +3; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight102
-
-