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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887358
Device Problem No Apparent Adverse Event (3189)
Patient Problems Necrosis (1971); Tissue Damage (2104); No Code Available (3191)
Event Date 03/19/2019
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
Samples taken at the time of the first washout (11/3) failed to grow any bacteria/ infection - captured as (b)(4). On (b)(6) 2019 the surgeon however was concerned that the extensive necrotic tissue surrounding the proximal femur would result in later issues and decided to remove all components and insert a temporary cement spacer. The femoral component was removed causing damage to the proximal femoral bone. A cement spacer inserted and the proximal femur cabled. Black metallosis was evident around the femoral taper (images uploaded to ecm). The acetabular component was removed, while maintaining acetabular bone and integrity. Male patient initials (b)(6).
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no devices were returned for evaluation. A review of complaint databases did not identify any anomalies. Root cause undetermined depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may 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.
 
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Brand NamePINNACLE MTL INS NEUT36IDX58OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8496687
MDR Text Key141367668
Report Number1818910-2019-90218
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2007
Device Catalogue Number121887358
Device Lot Number1057421
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 Received05/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2002
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: 04/09/2019 Patient Sequence Number: 1
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