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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 4/13 MM L; KNEE TIBIAL INSERT
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MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L; KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.12.0413FL
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 november 2018: lot 143217: (b)(4) items manufactured and released on 26 september 2014.Expiration date: 2019-08-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Infection followed by a liner exchange of a gmk-sphere knee 1 month after primary surgery.The liner was changed with a new one of the same size.
 
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Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8073330
Report Number3005180920-2018-00904
Device Sequence Number18893253
Product Code JWH
UDI-Device Identifier07630030862618
UDI-Public07630030862618
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 Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/15/2018
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 Date08/31/2019
Device Catalogue Number02.12.0413FL
Device Lot Number143217
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/17/2018
Initial Report FDA Received Date11/15/2018
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 Age66 YR
Patient Weight70
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