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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 AML 12.0 MMA 6.3 5/8 STD 12/14; AML IMPLANT : HIP FEMORAL STEM
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DEPUY INTERNATIONAL LTD. 8010379 AML 12.0 MMA 6.3 5/8 STD 12/14; AML IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 155703000
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 08/14/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The patient had a primer hip surgery on (b)(6) 2001.The doctor used aml stem.Now (after 17 years) this stem has broken - only the stem, the femur is undamaged.
 
Additional Manufacturer Narrative
(b)(4).
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
 
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Brand Name
AML 12.0 MMA 6.3 5/8 STD 12/14
Common Device Name
AML IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK  LS11 8 DT
MDR Report Key7859748
Report Number1818910-2018-68815
Device Sequence Number1980498
Product Code LPH
UDI-Device Identifier10603295059240
UDI-Public10603295059240
Combination Product (Y/N)N
Initial Reporter CountryHU
PMA/510(K) Number
K953694
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 08/14/2018
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
Operator of Device Health Professional
Device Catalogue Number155703000
Device Lot NumberXMC-14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Initial Date Received by Manufacturer 08/14/2018
Supplement Date Received by Manufacturer09/24/2018
12/20/2018
Initial Report FDA Received Date09/10/2018
Supplement Report FDA Received Date10/02/2018
12/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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