FDA Adverse Event Injury Summary report: N

AMISTEM H CEMENTLESS STEM NUMBER 3 STD

MDR report key: 4619978 · Received March 18, 2015

Report

Report Number: 3005180920-2015-00039
Event Type: Injury
Date Received: March 18, 2015
Product Code: MEH
PMA / PMN Number: K093944
Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 131570: (B)(4) MANUFACTURED AND RELEASED ON (B)(4)2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 78 ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY. FEMORAL HEAD CODE (B)(4) LOT 130909 (K072857): (B)(4)HEADS MANUFACTURED AND RELEASED ON (B)(4) 2013. EXPIRATION DATE: 2018-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. VERSAFITCUP DM LINER CODE 01.26.2850MHC LOT 132335 (K092265): (B)(4) MANUFACTURED AND RELEASED ON (B)(4) 2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. VERSAFITCUP DM CUP CODE 01.26.50MB LOT 131687 (K083116):(B)(4) MANUFACTURED AND RELEASED ON (B)(4) 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. ON (B)(4) 2015 WE WERE INFORMED THAT THE ITEMS WILL NOT RETURN BACK AND THEY ARE WITH THE PT.

Description of Event or Problem · 1

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
185048	AMISTEM H CEMENTLESS STEM NUMBER 3 STD	CEMENTLESS FEMORAL STEM MEH, LZO	MEH

Patients

Seq	Age	Sex	Outcome	Treatment
1