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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX56OD METAL ACETABULAR LINER

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DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX56OD METAL ACETABULAR LINER Back to Search Results
Catalog Number 121887456
Device Problem Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/27/2020
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
Pinnacle litigation records received. Litigation alleges toxic cobalt-chromium metal ions in the body causing pain, injury to the muscle, tissues and bone. Plaintiff also suffered emotional trauma and distress. Mri reported pseudotumor due to negative reaction to metal debris. Doi: (b)(6) 2009; dor: (b)(6) 2020: right hip.
 
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Brand NamePINNACLE MTL INS NEUT40IDX56OD
Type of DeviceMETAL ACETABULAR LINER
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds IN LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD - 8010379
st anthonys road
leeds IN LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11691194
MDR Text Key246273301
Report Number1818910-2021-08241
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2013
Device Catalogue Number121887456
Device Lot Number2654133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2021 Patient Sequence Number: 1
Treatment
UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM
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