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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMRL ZIRCONIA 28+0 S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMRL ZIRCONIA 28+0 S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 560028
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Tissue Damage (2104); Osteolysis (2377); Not Applicable (3189)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative

(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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Clinical database notification received for revision due to poly wear, pain, osteolysis, soft tissue injury, and squeaking. Doi: (b)(6) 1999; dor: (b)(6) 2018; (right, hip). Please note at time of initial implantation, the cup and poly were competitor product. A depuy head is being captured on this complaint as it was used off-label in conjunction with a competitor liner and was revised. There is no indication that the off-label use lead to the poly wear.

 
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Type of DeviceS-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7898357
MDR Text Key121035252
Report Number1818910-2018-70081
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK921111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial
Report Date 08/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number560028
Device LOT NumberSA109741
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
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 TREATMENT DATA
Date Received: 09/21/2018 Patient Sequence Number: 1
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