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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI RESECT AP BLOCK RM/LL SZ 7 PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. JRNY II UNI RESECT AP BLOCK RM/LL SZ 7 PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 74016417
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that during surgery, the posterior lug hole in the journey ii uni resection ap block rm/ll sz 7 left metal debris in the patient when drilling. Procedure continued with the same device, with a delay of less than 30 minutes. The patient was not harmed beyond the described event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameJRNY II UNI RESECT AP BLOCK RM/LL SZ 7
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11444085
MDR Text Key238591920
Report Number1020279-2021-01907
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK190085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number74016417
Device Catalogue Number74016417
Device LOT Number20CM05830
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 Received02/10/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/06/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/09/2021 Patient Sequence Number: 1
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