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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number 121887352
Device Problems Material Disintegration (1177); Difficult to Remove (1528); Naturally Worn (2988); Insufficient Information (3190)
Patient Problems Necrosis (1971); Pain (1994); Tissue Damage (2104); Anxiety (2328); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Depression (2361); Confusion/ Disorientation (2553); Not Applicable (3189)
Event Date 10/24/2017
Event Type  malfunction  
Manufacturer Narrative
Product complaint: (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. 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 was previously reported, litigation alleges injury, metallosis, physical impairment, disfigurement, mental anguish,tissue necrosis, heavy metal poisoning, loss of bone, emotional distress, anxiety and depression.
 
Event Description
Ppf alleges loosening of cup, abductor muscle repair and metal wear.
 
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
The patient was revised to address hip pain. The surgeon decided to take the patient back to surgery and replace cup and head. The stem was not loose and was not replaced. He was unable to replace just the metal liner so he removed the cup. He was unable to get good fixation with a revision cup due to bone quality and posterior wall absence, and had to cement cup and liner in acetabulum. He replaced with appropriate size head.
 
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Brand NamePINNACLE MTL INS NEUT36IDX52OD
Type of DeviceHIP ACETABULAR INSERT/LINER
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 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key7045285
MDR Text Key113344101
Report Number1818910-2017-29388
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 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 Expiration Date11/30/2012
Device Catalogue Number121887352
Device Lot Number2507646
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 Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2007
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: 11/20/2017 Patient Sequence Number: 1
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