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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY ACETABULAR LINER; HIP ACETABULAR INSERT/LINER
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DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY ACETABULAR LINER; HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number UNK-HIP
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 12/21/2015
Event Type  Injury  
Manufacturer Narrative
Udi: unavailable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pfs and medical records received.After review of the medical records for mdr reportability, the patient was revised for leg length discrepancy due to a long femoral neck, pain, impingement, and subluxations.There is no indications of what was causing the impingement.Only the femoral head and liner were revised.It should be noted the cup was noted to be well fixed with evidence of loosening.The cup wasn't revised, so it is reasonable to assume there is a typo within the medical records.
 
Manufacturer Narrative
Pfs and medical records received.After review of the medical records for mdr reportability, the patient was revised for leg length discrepancy due to a long femoral neck, pain, impingement, and subluxations.There is no indications of what was causing the impingement.Only the femoral head and liner were revised.It should be noted the cup was noted to be well fixed with evidence of loosening.The cup wasn't revised, so it is reasonable to assume there is a typo within the medical records.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.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.
 
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
HIP ACETABULAR INSERT/LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key6106793
MDR Text Key60035734
Report Number1818910-2016-31583
Device Sequence Number1
Product Code JDJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 11/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK-HIP
Was Device Available for Evaluation? No
Date Manufacturer Received09/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient Weight68
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