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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP INSTRUMENTS

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP INSTRUMENTS Back to Search Results
Catalog Number UNK HIP INSTRUMENTS
Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
The reported implants were implanted to the patient¿s hip joint via tha on (b)(6) 2018.It was reported that the surgeon found a thin wire-like object (please refer attached picture) was caught between bone and cup just right before closing a surgical incision.The foreign material was retrieved from the patient¿s hip joint, so that there was no foreign material in the patient¿s body.There was less than 30min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
 
Manufacturer Narrative
Pc-(b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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
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.Product complaint # (b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 HIP INSTRUMENTS
Type of Device
HIP INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7946368
MDR Text Key123053159
Report Number1818910-2018-71705
Device Sequence Number1
Product Code JDG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/10/2018
2 Devices were Involved in the Event: 1   2  
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 Catalogue NumberUNK HIP INSTRUMENTS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Initial Date Manufacturer Received 09/10/2018
Initial Date FDA Received10/09/2018
Supplement Dates Manufacturer Received10/16/2018
04/11/2019
Supplement Dates FDA Received10/18/2018
04/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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