FDA Adverse Event Injury Summary report: N

3005180920-2018-00592

MDR report key: 7734717 · Received July 31, 2018

Report

Report Number: 3005180920-2018-00592
Event Type: Injury
Date Received: July 31, 2018
Date of Event: July 11, 2018
Report Date: July 31, 2018
PMA / PMN Number: K102437
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEWS PERFORMED ON 27 JULY 2018: LOT 177644: 12 ITEMS MANUFACTURED AND RELEASED ON 09 JANUARY 2018. EXPIRATION DATE: 2022-12-11. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW FOR GMK-REVISION FIXED TIBIAL INSERT SC # 3/10MM, (B)(4), LOT. 174955 (K103170): 29 ITEMS MANUFACTURED AND RELEASED ON 09 NOVEMBER 2017. EXPIRATION DATE: 2022-10-09 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. BATCH REVIEW FOR GMK-REVISION FIXED TIBIAL TRAY CEMENTED # 3 R, (B)(4), LOT. 174932 (K123721): 35 ITEMS MANUFACTURED AND RELEASED ON 29 NOVEMBER 2017. EXPIRATION DATE: 2022-11-09. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW FOR GMK PATELLA RESURFACING # 3, (B)(4), LOT. 174642 (K090988): 120 ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2017. EXPIRATION DATE: 2022-10-08. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 105 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATHOGEN IS UNKNOWN.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention