• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM PINNACLE MTL INS NEUT36IDX54OD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM PINNACLE MTL INS NEUT36IDX54OD Back to Search Results
Catalog Number 121887354
Device Problems Corroded (1131); Material Disintegration (1177); Metal Shedding Debris (1804); 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 08/10/2016
Event Type  malfunction  
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.
 
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 pseudotumor. The patient has developed elevated cobalt and chromium levels. An mri examination shows pseudotumors around both hips. Revision note reported cloudy fluid in the joint. There was some blackened pseudotumor present along the posterior capsule that extended up into the region of the abductors and trochanteric bursa. There was some corrosion on the taper of the femoral component.
 
Manufacturer Narrative
(b)(4).
 
Event Description
In addition to what previously alleged, ppf alleges metal wear. Doi: (b)(6), 2008 - dor: (b)(6), 2016 (left hip).
 
Manufacturer Narrative
(b)(4). 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
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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
Oct 24, 2017: litigation received. Litigation alleges pain and elevated metal ion levels in the blood. Revision reported metallosis and pseudotumor, described as blackened pseudotumor present along the posterior capsule that extend up into the region of the abductors and trochanteric bursa and corrosion on the taper of the femoral component. This complaint was updated on oct 31, 2017.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM
Type of DevicePINNACLE MTL INS NEUT36IDX54OD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds IN LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key7046104
MDR Text Key104203368
Report Number1818910-2017-29438
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 company representative,consum
Reporter Occupation Attorney
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? No
Device Operator
Device Catalogue Number121887354
Device Lot Number2436899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2007
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
-
-