FDA Adverse Event Injury Summary report: N

QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

MDR report key: 7129029 · Received December 19, 2017

Report

Report Number: 3005180920-2017-00756
Event Type: Injury
Date Received: December 19, 2017
Date of Event: November 20, 2017
Report Date: December 19, 2017
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JDI
UDI-DI: 07630030802058
PMA / PMN Number: K082792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEWS PERFORMED ON 27 NOVEMBER 2017: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4 REFERENCE 01.12.024 (K082792): (B)(4). ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 REFERENCE 01.26.45.1150 (K122911): (B)(4). BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 REFERENCE 01.29.205 (K112115): (B)(4). MECTACER CERAMIC LINER Ø 32 / E REFERENCE 01.29.410 (DEVICE NOT MARKETED IN US): (B)(4). CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 24 NOVEMBER 2017: INFECTION IN CEMENTLESS PRIMARY THA 1,5 YEARS AFTER PRIMARY. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. PRELIMINARY INVESTIGATION BASED ON THE PICTURES RECEIVED BY THE COMPLAINER PERFORMED BY R AND D HIP MANAGER ON 19 DECEMBER 2017: FROM THE IMAGES NO CONCLUSION CAN BE DRAWN. ON ALL THE IMPLANTS SOME RESIDUAL OF BOTH BLOOD AND BONE CAN BE NOTED.

Description of Event or Problem · 1

PATIENT WAS COMPLAINING OF PAIN, TESTS WERE DONE TO DETERMINE THAT THE HIP HAD A STAPHYLOCCOCUS INFECTION. SURGEON DECIDED TO PERFORM STAGE ONE REVISION AND REMOVED ALL OF THE CURRENT IMPLANTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
908674	QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4	CEMENTLESS HA COATED STEM	JDI	MEDACTA INTERNATIONAL SA		155091	07630030802058

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention