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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY ACETABULAR LINER; PINNACLE MTL INS NEUT36IDX52OD

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DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY ACETABULAR LINER; PINNACLE MTL INS NEUT36IDX52OD Back to Search Results
Catalog Number 121887352
Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Infarction, Cerebral (1771); Pain (1994); Heart Failure (2206); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Event Date 10/20/2017
Event Type  Injury  
Manufacturer Narrative
This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Litigation record received.Litigation alleges corrosion and friction wear causing toxic cobalt-chromium metal debris, pain, discomfort and limited mobility.There is no report of revision at this time.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Depuy considers the investigation closed at this time.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
In addition to what was previously litigated, patient also alleges metallosis, inability to do daily activities.After review of medical records, updated product and lot information.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Ppf alleges stroke or heart failure.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  product complaint #: (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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN DEPUY ACETABULAR LINER
Type of Device
PINNACLE MTL INS NEUT36IDX52OD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7040543
MDR Text Key92304244
Report Number1818910-2017-29218
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 consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2013
Device Catalogue Number121887352
Device Lot Number2786333
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/20/2017
Initial Date FDA Received11/17/2017
Supplement Dates Manufacturer Received12/01/2017
02/15/2018
07/27/2018
12/31/2018
Supplement Dates FDA Received12/05/2017
02/21/2018
08/23/2018
01/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
Patient Weight97
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