FDA Adverse Event Injury Summary report: N

AMISTEM H, HA COATED STEM SIZE 3 LAT

MDR report key: 6947953 · Received October 13, 2017

Report

Report Number: 3005180920-2017-00586
Event Type: Injury
Date Received: October 13, 2017
Date of Event: September 14, 2017
Report Date: October 13, 2017
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030804199
PMA / PMN Number: K093944
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 13 OCTOBER 2017. LOT 133082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 13 OCTOBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: HIP REVISION SURGERY OCCURRED 3,5 YEARS AFTER PRIMARY CEMENTLESS THA. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1, 2, 6 AND 7 SIGN OF STEM LOOSENING. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED MID-TERM ADVERSE EVENT AFTER PRIMARY CEMENTLESS THA: CAUSES ARE OFTEN UNKNOWN. ACCORDING TO THE INFORMATION COLLECTED, THE REASON OF THIS EVENT CANNOT BE DETERMINED.

Description of Event or Problem · 1

REVISION SURGERY DUE TO ASEPTIC LOOSENING OF AN AMISTEM-H.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
727149	AMISTEM H, HA COATED STEM SIZE 3 LAT	CEMENTLESS FEMORAL STEM	LZO	MEDACTA INTERNATIONAL SA		133082	07630030804199

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Required Intervention