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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP HEAD METAL
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Ossification (1428); Foreign Body Reaction (1868); Joint Dislocation (2374); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2020
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.
 
Event Description
An article/literature was received entitled "have newer bearing surfaces changed expectations regarding the longevity of total hip arthroplasty?".
 
Manufacturer Narrative
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 number was not provided.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b1 (product problem), d10.
 
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Brand Name
UNK HIP FEMORAL HEAD METAL
Type of Device
METAL FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12235895
MDR Text Key263829658
Report Number1818910-2021-16235
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 health professional,literatur
Type of Report Initial,Followup
Report Date 07/09/2021
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 HEAD METAL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/09/2021
Initial Date FDA Received07/28/2021
Supplement Dates Manufacturer Received08/02/2021
Supplement Dates FDA Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AML OR PRODIGY; DURALOC LOCKING RING; PINNACLE CUP/DURALOC CUP; UNK HIP ACETABULAR LINER CERAMIC; UNK HIP ACETABULAR LINER METAL ULTIMA; UNK HIP ACETABULAR LINER POLY; UNK HIP FEMORAL HEAD CERAMIC; UNK HIP FEMORAL HEAD METAL
Patient Outcome(s) Required Intervention;
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