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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX54OD HIP ACETABULAR INSERT/LINER

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DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX54OD HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number 121887354
Device Problems Insufficient Information (3190); Noise, Audible (3273)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032)
Event Date 10/26/2017
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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Update oct 26, 2017: pfs and medical records received. Pfs also alleges muscle spasms, limited range of motion and audible clicks. After review of medical records, there is no new information. Updated part and lot information. This complaint was updated on: nov 2, 2017.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Update oct 26, 2017: pfs and medical records received. Pfs also alleges muscle spasms, limited range of motion and audible clicks. After review of medical records, there is no new information. Updated part and lot information. This complaint was updated on nov 2, 2017.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Update oct 26, 2017: pfs and medical records received. Pfs also alleges muscle spasms, limited range of motion and audible clicks. After review of medical records, there is no new information. Updated part and lot information. This complaint was updated on: nov 2, 2017.
 
Manufacturer Narrative
(b)(4). Investigation summary: 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
Complaint description: aug 17, 2017: litigation records received. Litigation alleges pain, suffering, and debility. There is no revision reported at this time. No part and lot information provided. Update oct 26, 2017: pfs and medical records received. Pfs also alleges muscle spasms, limited range of motion and audible clicks. After review of medical records, there is no new information. Updated part and lot information. This complaint was updated on: nov 2, 2017.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate.
 
Event Description
On (b)(6) 2017: litigation records received. Litigation alleges pain, suffering, and debility. There is no revision reported at this time. No part and lot information provided.
 
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Brand NamePINNACLE MTL INS NEUT36IDX54OD
Type of DeviceHIP ACETABULAR INSERT/LINER
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 IN LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key6869379
MDR Text Key104321654
Report Number1818910-2017-24833
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 consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2015
Device Catalogue Number121887354
Device Lot Number3079953
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 Received08/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2010
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: 09/15/2017 Patient Sequence Number: 1
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