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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 STD OFF; HIP FEMORAL STEM/SLEEVE
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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 STD OFF; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 157001100
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 09/09/2014
Event Type  Injury  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.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
Patient was revised to address elevated metal ion levels (cobalt=73.5, chromium=0.2), and metallosis.Update rec'd 1/18/2016: litigation received.Litigation also alleges pain.An unknown stem is being added for the elevated metal ions.This complaint was updated on: 1/25/2016.
 
Manufacturer Narrative
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 still 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
(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Update 05/09/2016 - pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain, limited mobility, swelling and metallosis.Revision surgical report noted metallosis, staining, and early cup loosening with abundant gray fluid, complete staining of synovium, acetabular posterior bone had begun to erode and metal stained tissue and bone behind cup.Pathology report noted chronic inflammation.Part/lot updated and cup added for loosening.The complaint was updated on: may 31, 2016.
 
Manufacturer Narrative
No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.
 
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.Udi: (b)(4).
 
Event Description
Ppf alleges metal wear.
 
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Brand Name
SUMMIT POR TAPER SZ4 STD OFF
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key5394016
MDR Text Key36913609
Report Number1818910-2016-12057
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
PK001991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/18/2016
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 Catalogue Number157001100
Device Lot NumberB49H41000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/18/2016
Initial Date FDA Received01/27/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
03/25/2019
12/03/2019
Supplement Dates FDA Received03/02/2016
06/06/2016
07/12/2016
04/11/2019
12/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight68
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