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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER

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DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number 121887352
Device Problems Metal Shedding Debris (1804); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Muscle Weakness (1967); Nausea (1970); Pain (1994); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Injury (2348); Depression (2361); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191)
Event Date 09/25/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Pfs and medical records received. In addition to what were previously alleged, pfs alleges limping, muscle ache, fatigue, nausea, bruising, increasing depression and elevated metal ions. After the review of medical records for mdr reportability, patient was revised to address failed left total hip replacement with chronic elevated cobalt chromium ions and disruption of the gluteus medius and minimus tendons. Revision notes stated that there was a slight fluid fluctuance overlying the greater trochanter, gluteus medius and minimus tendons disruption, blood tinged dark fluid, tissue reaction, reactive hypertrophic synovitis, corrosion was noted, and metallosis. Clinical notes reported chronic hip pain and swelling. Stem added due to reported elevated metal ion levels and corrosion but not revised. There are no lab results reported.
 
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
Litigation received. In addition to what was previously alleged, litigation also alleges elevated metal ion levels, large fluid collection in the joint, muscle damage, and muscle weakness. Surgeon¿s operative notes reported dark gray bursa, moderately large amount of blood tinged dark fluid was removed, reactive hypertrophic synovitis with acute synovitis and fluid formation, some metallosis membrane removed from the joint itself and corrosion at the taper.
 
Manufacturer Narrative
(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
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address pain.
 
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Brand NamePINNACLE MTL INS NEUT36IDX52OD
Type of DeviceHIP ACETABULAR INSERT/LINER
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 LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key6969644
MDR Text Key104089320
Report Number1818910-2017-27269
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/05/2008
Device Catalogue Number121887352
Device Lot Number1149936
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 Received07/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/23/2017 Patient Sequence Number: 1
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