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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20F XXL; HIP INSTRUMENTS : FEMORAL TRIALS

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DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20F XXL; HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 2576-20-130
Device Problems Material Discolored (1170); Material Deformation (2976); Material Twisted/Bent (2981); Naturally Worn (2988); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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
It was reported that the office sets instrument was worn and cannot read.No surgery was affected.
 
Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: investigation summary: examination of the returned instrument confirmed the reported observation.The root cause is attributed to misuse and heavy usage.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.The device associated with this report was not returned.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.Territory 226 reports that the office set instrument was worn and cannot read.The device associated with this report was not returned.Provided information states the instrument is worn.With no instrument returned and no more information, no root cause can be determined for this specific instrument.A lot specific complaint database search was not possible as the lot code required was not provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.Update: (b)(6) 2019.Territory 226 reports that the office set instrument was worn and cannot read.Examination of the returned instrument confirmed the complaint; the trial is extremely worn and damaged.The trial exhibits numerous gouges, nicks, and scratches.Portions of the anodized coating is missing.Both sides of the trial are damaged.The side opposite of the lot information is extremely damaged due to misuse/heavy usage.Damage can occur once the trial sleeves have been seated if any bone fragments/uneven surfaces exist from the earlier neck resection.It is suspected that users are leaving the trials in place when cleaning up / filing off any extra bone and in turn damaging the top surface of the trial sleeves.The root cause is attributed to misuse/ heavy usage.Based on the investigation, the need for corrective action is not indicated.Continue to monitor complaints under post market surveillance sep-419.If information is obtained that was not available for the initial 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.Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the reported observation.The root cause is attributed to misuse and heavy usage.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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ZT TRIAL SLEEVE 20F XXL
Type of Device
HIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8711529
MDR Text Key148412318
Report Number1818910-2019-96246
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10603295146797
UDI-Public10603295146797
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2576-20-130
Device Catalogue Number257620130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Initial Date Manufacturer Received 05/20/2019
Initial Date FDA Received06/19/2019
Supplement Dates Manufacturer Received05/29/2019
10/28/2019
05/06/2020
Supplement Dates FDA Received06/21/2019
11/04/2019
05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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