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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number UNK HIP ACETABULAR POLY/METAL
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 08/15/2022
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022, the patient underwent the bipolar hip arthroplasty with the actis collared.The surgery was completed successfully without any surgical delay.After the surgery, dislocation occurred on (b)(6) 2022.Therefore, the total hip arthroplasty revision surgery will be performed on (b)(6) 2022.The stem will be removed, and anterior torsional adjustments will be made with implants from another company.The surgeon will use dual mobility.The cause of the dislocation is unknown.No further information is available.
 
Manufacturer Narrative
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
Event Description
A.Was the stem noted, to be mispositioned? the stem dislocation occurred, on (b)(6) 2022.1.Has the revision taken place? if so, when, and what was actually removed? on (b)(6) 2022, a revision surgery was performed.The stem was removed and replace to another company stem.2.Did the bipolar dislocate? no further information is available.3.Why was the stem to be removed, if it was a dislocation event? due to the revision from bha to tha.4.We understand, that anterior torsional adjustments will be made.Was there a positioning issue with actis stem? no further information is available.5.Which components dislocated? no further information is available.
 
Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.Corrected h6: (patient).
 
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Brand Name
UNKNOWN HIP ACETABULAR POLY/METAL HEMI
Type of Device
HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key15360831
MDR Text Key299289321
Report Number1818910-2022-17146
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/06/2022
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? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR POLY/METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2022
Initial Date FDA Received09/06/2022
Supplement Dates Manufacturer Received09/07/2022
09/13/2022
Supplement Dates FDA Received09/12/2022
09/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ACTIS COLLARED STD SIZE 4; UNKNOWN HIP ACETABULAR POLY/METAL HEMI; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
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