FDA Adverse Event Injury Summary report: N

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

MDR report key: 10366564 · Received August 5, 2020

Report

Report Number: 3005180920-2020-00488
Event Type: Injury
Date Received: August 5, 2020
Date of Event: July 9, 2020
Report Date: August 5, 2020
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030826740
PMA / PMN Number: K121416
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 15 JULY 2020: LOT 147677: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. OTHER DEVICE INVOLVED IN THE EVENT: GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 LOT. 141655 (K113571). BATCH REVIEW PERFORMED ON 15 JULY 2020: LOT 141655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

Description of Event or Problem · 1

THE PATIENT CAME IN REPORTING INSTABILITY AND ANTERIOR KNEE PAIN. UPON INSPECTION AFTER AN INCISION WAS MADE, IT WAS OBSERVED THAT THERE WAS A FRACTURE AT THE SUPERIOR POLE OF THE PATELLA. THE SURGEON SWAPPED THE POLY WITH A HIGHER ONE (11MM) AND RESURFACED THE PATELLA 4 YEARS AND 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
833096	GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R	TIBIAL INSERT FIXED	JWH	MEDACTA INTERNATIONAL SA	02.12.0510FR	147677	07630030826740

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention