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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD
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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD METAL ASR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Distress (2329); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/24/2020
Event Type  Injury  
Event Description
Litigation letter received.Litigation alleges pain, suffering and emotional distress, excessive levels of chormium and cobalt, as well as economic loss and punitive damages.Doi: (b)(6) 2006, dor: (b)(6) 2020, 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.Initial reporter occupation: lawyer.(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.Initial reporter occupation: lawyer.(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
Litigation letter received.Litigation alleges pain, suffering and emotional distress, excessive levels of chormium and cobalt, as well as economic loss and punitive damages.Doi: (b)(6) 2006, dor: (b)(6) 2020, right hip.
 
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: a1, a2 dob, a4, b5, h6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Pfs records received.Patient is experiencing arising waste material from the implants metal on metal structure.
 
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Brand Name
UNK HIP FEMORAL HEAD METAL ASR
Type of Device
METAL FEMORAL HEAD
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
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13336412
MDR Text Key285543569
Report Number1818910-2022-01502
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD METAL ASR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight104 KG
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