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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 43; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 43; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890243
Device Problems Corroded (1131); Degraded (1153)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 11/28/2018
Event Type  Injury  
Manufacturer Narrative
(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
Asr plaintiff preliminary disclosure received.Ppd has no allegation provided.Doi: (b)(6) 2008; dor: (b)(6) 2018: right hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
 
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Brand Name
ASR UNI FEMORAL IMPL SIZE 43
Type of Device
ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10302115
MDR Text Key199683962
Report Number1818910-2020-16381
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2013
Device Catalogue Number999890243
Device Lot Number2557511
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ASR ACETABULAR CUPS 48; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 43; SUMMIT POR TAPER SZ5 STD OFF; UNKNOWN HIP FEMORAL STEM; ASR ACETABULAR CUPS 48; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 43; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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