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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L; KNEE IBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L; KNEE IBIAL INSERT Back to Search Results
Catalog Number 02.12.0211FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2019: lot 176146: (b)(4) items manufactured and released on 05-jan-2018.Expiration date: 2022-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 7 months after primary the surgeon revised the patient knee for an infection case.Liner swap performed successfully.
 
Additional Manufacturer Narrative
Additional information received on july 29th 2019: the pathogen is propionebacterium acnes.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L
Common Device Name
KNEE IBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8830087
Report Number3005180920-2019-00609
Device Sequence Number2588106
Product Code JWH
UDI-Device Identifier07630030862526
UDI-Public07630030862526
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K140826
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 07/31/2019
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
Operator of Device Health Professional
Device Expiration Date12/13/2022
Device Catalogue Number02.12.0211FL
Device Lot Number176146
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2019
Supplement Date Received by Manufacturer06/26/2019
Initial Report FDA Received Date07/26/2019
Supplement Report FDA Received Date07/31/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age58 YR
Patient Weight80
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