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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY PINNACLE LINER 36MM X 52MM PINNACLE MTL INS NEUT36IDX52OD

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DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY PINNACLE LINER 36MM X 52MM PINNACLE MTL INS NEUT36IDX52OD Back to Search Results
Catalog Number 121887352
Device Problems Corroded (1131); Material Disintegration (1177); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/13/2016
Event Type  Injury  
Event Description
In addition to what was previously litigated, patient also alleges right groin discomfort, developed numbness in her legs, spasms, decreased range of motion. Patient continues to experience muscle tightness, pain and intermittent muscle spasm. After review of medical records for mdr reportability it was reported that the patient was revised to address metallosis and pseudotumors. Patient had developed pain and has elevated cobalt and chromium levels. Mri examination shows evidence of pseudotumors around her hips. Revision note reported a cloudy fluid in the joint, this was the fluid that is typically seen in metallosis. There was a lot of pseudotumor posteriorly. There was a lot of corrosion on the trunnion of the taper and in the metal liner.
 
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).
 
Event Description
In addition to what previously alleged, ppf alleges metal wear. Updated patient's identifier, patient harm, law firm in the facility name. Added lawyer in the associated contact and patient's address.
 
Manufacturer Narrative
Udi: unavailable. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. See section d for any product information received. This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation received. Litigation alleges pain and elevated metal ions. Revision noted metallosis with pseudotumor and corrosion on the trunnion of the taper and of the metal liner.
 
Manufacturer Narrative
No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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 NameUNKNOWN DEPUY PINNACLE LINER 36MM X 52MM
Type of DevicePINNACLE MTL INS NEUT36IDX52OD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds IN LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key7046336
MDR Text Key117024104
Report Number1818910-2017-29426
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2011
Device Catalogue Number121887352
Device Lot Number2175626
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2006
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: 11/20/2017 Patient Sequence Number: 1
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