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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX70OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX70OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1221-40-170
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2020
Event Type  Injury  
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 patient had their hip operated on at (b)(6) by dr (b)(6) on (b)(6) 2019. This was also a revision case, but i am not sure of when the original procedure date. It was not in the operative notes. Revision was being done by dr (b)(6). Due to patient instability. Dr (b)(6) believed the acetabular component was not positioned properly and needed to be adjusted. All of the implants were removed from the acetabular side of the patient, and replaced with zimmer components. Dr (b)(6) felt that the femoral stem was well fixed and opted to leave it. Once the zimmer cup was inserted, a trial reduction was performed with our 40mm head trial. A 40mm +12 was found to be satisfactory and implanted. Closing process began. Doi: (b)(6) 2019; dor: (b)(6) 2020; affected side: right hip.

 
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Brand NameALTRX +4 10D 40IDX70OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key10159584
Report Number1818910-2020-13915
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1221-40-170
Device Catalogue Number122140170
Device LOT NumberH62196
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 Received07/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2017
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: 06/16/2020 Patient Sequence Number: 1
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