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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR METAL HEMI MODULAR CATHCART

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR METAL HEMI MODULAR CATHCART Back to Search Results
Catalog Number UNK HIP ACETABULAR METAL HEMI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 07/18/2022
Event Type  Injury  
Event Description
It was reported that the patient had a hemi hip placed in 2004.This has done well but she has had increasing hip pain.Today her hemi was converted to a tha.She retained her pressfit summit stem.The mod cathcart head and neck were removed and a pinnacle cup and liner was placed.There was no loosening, no broken parts and time was not extended due to depuy products.Doi: 2004, dor: (b)(6) 2022, affected side: left hip.
 
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).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.
 
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Brand Name
UNK HIP ACETABULAR METAL HEMI MODULAR CATHCART
Type of Device
ACETABULAR 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 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key15156358
MDR Text Key297147764
Report Number1818910-2022-14881
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2022
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? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR METAL HEMI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/18/2022
Initial Date FDA Received08/03/2022
Supplement Dates Manufacturer Received08/12/2022
Supplement Dates FDA Received08/14/2022
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
47 ENDO HEAD; NECK
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexFemale
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