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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT28IDX50OD HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT28IDX50OD HIP ACETABULAR LINERS Back to Search Results
Catalog Number 121889150
Device Problems Material Disintegration (1177); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problems Bruise/Contusion (1754); Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348)
Event Date 05/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Pfs and medical records received. Pfs alleges no new information. After review of medical records for mdr reportability, operative notes indicate that the patient was revised due to metallosis of left hip status post remote metal on metal total hip arthroplasty, elevated serum cobalt and chromium. Progressive pain and marked elevation of serum cobalt chromium ions were also reported in the revision operative notes. It was also noted that the wound had a relatively minor degree of metallic staining of the soft tissues, particularly around the acetabular component, however there was no substantial staining of joint fluid. Clinic visits further show that patient suffered from peri-incisional ecchymosis, discomfort, difficulty sleeping and pain post implantation.
 
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, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).
 
Event Description
In addition to previous allegations, ppf alleges metal wear and elevated metal ions.
 
Manufacturer Narrative
Product complaint # (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 pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, metal toxicity, bone erosion, pseudotumors, implant failure, bursitis, nerve damage and emotional distress. (b)(6) 2005 ; (b)(6) 2017 (left hip).
 
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Brand NamePINNACLE MTL INS NEUT28IDX50OD
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 46581-0988
6103142063
MDR Report Key7189217
MDR Text Key110480358
Report Number1818910-2018-51179
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number121889150
Device Lot Number1040907
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 Received12/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/15/2018 Patient Sequence Number: 1
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