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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 Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Depression (2361); Osteolysis (2377); Ambulation Difficulties (2544)
Event Date 08/04/2017
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
Claim letter alleges pain, depression, loss of income, antalgic gait, tenderness to palpation, limited range of motion, discomfort, stiffness, elevated metal ions and metallosis. After review of medical records the patient was revised to address failed left tha secondary to adverse reaction to metal debris. Clinical findings of mri reported there were scattered debris within the joint fluid, alval, mild reactive muscle edema and soft tissue edema around the left hip and there is a clicking and popping sounds. It was confirmed in the operative note reported osteolysis of the femur, adverse reaction to metal debris and pseudotumor formation, a brownish fluid like coffee ground appearance, pseudocyst from the capsule, trunnionosis within the head and trunnion. Morse taper had a lot of metallosis, soft tissue necrosis and implant wear. Lab results for crp and sedimentation rate were elevated. While metal ions level was below 7ppb.
 
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
Der states that the surgeon performed a head and liner swap on a patient with metal on metal hip. Bearing failure was due to metalosis from the head and liner rubbing the stem trunnion. Stem and sleeve were well fixed and did not need to be taken out. No further patient information is available.
 
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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
6103142063
MDR Report Key6838366
MDR Text Key107016066
Report Number1818910-2017-24020
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number121887352
Device Lot Number1065510
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 Received12/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2002
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: 09/01/2017 Patient Sequence Number: 1
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