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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800756
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/05/2021
Event Type  Injury  
Event Description
Asr litigation record received.Litigation alleges elevated metal ions resulting to hip pain.Doi: (b)(6) 2007, dor: (b)(6) 2021, left hip.
 
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.
 
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.
 
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.Updated: h6 (clinical code) to capture blood heavy metal increased.E3 initial reporter occupation: lawyer.
 
Event Description
Pfs alleges left hip pain, limited adl and elevated metal ions.After review of the medical records the patient was revised to address metallosis, cobalt chromium toxicity and pseudotumor.Operative note reported alval , metallosis in the stem and a large fluid collection with necrotic synovium.Encountered.
 
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: a2 (age), a4, b5, b6, b7, d4 (procode,lot,udi), g4, h4 and h6 (patient) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand Name
ASR ACETABULAR CUPS 56
Type of Device
ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14242881
MDR Text Key290380071
Report Number1818910-2022-07809
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number999800756
Device Lot Number2248988
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ADAPTER SLEEVE 11/13 +0.; ASR ACETABULAR CUPS 56.; ASR UNI FEMORAL IMPL SIZE 49.; S-ROM*SLEEVE PRX ZTT, 18D-LRG.; SROM STM STD 36+12L 13X18.; UNK HIP FEMORAL HEAD METAL ASR.; UNK HIP FEMORAL SLEEVE ASR.; UNK HIP FEMORAL STEM.
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient SexFemale
Patient Weight79 KG
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