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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 3; PATELLAR IMPLANT
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MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 3; PATELLAR IMPLANT Back to Search Results
Model Number 02.07.0035RP
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Pain (1994)
Date of Event 12/14/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 december 2020: lot 1902822: (b)(4) items manufactured and released on 21-jul-2019.Expiration date: 2024-06-04.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
The patient came in reporting pain due to a loose patella implant.1 year and 2 months after primary the surgeon revised the patella implant and poly and the surgery was completed successfully.
 
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Brand Name
GMK-SPHERE PATELLA RESURFACING SIZE 3
Common Device Name
PATELLAR IMPLANT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11147524
Report Number3005180920-2021-00031
Device Sequence Number14320668
Product Code JWH
UDI-Device Identifier07630030815768
UDI-Public07630030815768
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/11/2021
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 Date06/04/2024
Device Model Number02.07.0035RP
Device Catalogue Number02.07.0035RP
Device Lot Number1902822
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2020
Initial Report FDA Received Date01/11/2021
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 Age61 YR
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