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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-352
Device Problem Noise, Audible (3273)
Patient Problems Arrhythmia (1721); Headache (1880); Pyrosis/Heartburn (1883); Itching Sensation (1943); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Tinnitus (2103); Discomfort (2330); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the patient that "i had my right hip & knee replaced (b)(6) 2006 and my left hip replaced (b)(6) 2007. I began having left hip problems in 2016. I went to the original operating doctor to have it checked. At that time he did not find a solution for my discomfort. He did, however take a cobalt test at that time. It came back at 7. 2. This year he took another cobalt test on (b)(6) 2020 and the results were 16. 4. After review of medical records, it was determined that the patient experienced limited mobility accompanied by sensation that hip ball has come out of the socket and went back in. In 2016 patient felt/heard an audible pop. Revision notes stated that a scar tissue was removed. Head and liner were revised. Doi: (b)(6) 2007; dor: (b)(6) 2020; (left hip).
 
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Brand NamePINNACLE MTL INS NEUT36IDX52OD
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. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11474785
MDR Text Key239511098
Report Number1818910-2021-05000
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2011
Device Model Number1218-87-352
Device Catalogue Number121887352
Device Lot Number2223567
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 Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/12/2021 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT POR TAPER SZ5 HI OFF
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