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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT28IDX48OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT28IDX48OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121889148
Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problems Inflammation (1932); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)
Event Date 02/08/2012
Event Type  Injury  
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
Pinnacle ppf and medical records received. Pfs alleges dislocation and metallosis. After review of medical records for mdr reportability, the patient was revised to address metallosis, inflammation, and previous dislocation. Surgical notes also reported pruritus due to pain and muscle spasm. Blood work also determined that patient had high metal levels and reported that the cup was exchanged with findings of inflammation and moderate amount of dark tinged fluid with consistent metallosis and consistent pain. The patient also had an anemia of acute blood loss not necessitating transfusion. Doi: (b)(6) 2009; dor: (b)(6) 2012; left hip.
 
Manufacturer Narrative
After review of the medical records, it has been determined that this product has been reported twice. This duplication is an error. This report will be rejected.
 
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Brand NamePINNACLE MTL INS NEUT28IDX48OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581-0988
5743725905
MDR Report Key7506463
MDR Text Key107983781
Report Number1818910-2018-59372
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2014
Device Catalogue Number121889148
Device Lot Number2856740
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 Received05/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/06/2009
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: 05/11/2018 Patient Sequence Number: 1
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