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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-356
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(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
The primary surgery was performed on (b)(6) 2009 via tha. It was reported that the removal surgery was performed by explanting the cup (manufactured by kyocera, p/n: 121780056, lot#: 00277), the liner (p/n: 121887356), the head (p/n: 962712000) due to suspected infection caused by pain, and indwelled cement spacer molds (date of surgery was unknown). The stem (p/n: 961315000) was retained at this time, and the revision surgery was scheduled to be performed about 3 months later by explanting the stem and implanting implants after confirming sedation of infection (date of surgery was not fixed yet). The stem is planning to be returned after the revision surgery has been performed. No further information is available.
 
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Brand NamePINNACLE MTL INS NEUT36IDX56OD
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 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9686803
MDR Text Key178351184
Report Number1818910-2020-04347
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1218-87-356
Device Catalogue Number121887356
Device Lot Number2443338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2007
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: 02/10/2020 Patient Sequence Number: 1
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