FDA Adverse Event Malfunction Summary report: N

M2A-MAGNUM 42-50 TPR INSRT STD 0/0MMT1

MDR report key: 8103410 · Received November 26, 2018

Report

Report Number: 0001825034-2018-10871
Event Type: Malfunction
Date Received: November 26, 2018
Date of Event: November 8, 2016
Report Date: December 21, 2018
Manufacturer: ZIMMER BIOMET, INC.
Product Code: KWA
PMA / PMN Number: K042037
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem · 0

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative · 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS- PART: 103209 NAME: TAPERLOC POR FMRL 17.5X155 LOT: 565620, PART: 157450 NAME: M2A-MAGNUM MOD HD SZ 50MM LOT: 137430, PART: US157856 NAME: M2A-MAGNUM PF CUP 56ODX50ID LOT: 990940.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE TAPER ADAPTER COLD WELDED TO STEM DURING A REVISION SURGERY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
941393	M2A-MAGNUM 42-50 TPR INSRT STD 0/0MMT1	PROSTHESIS, HIP	KWA	ZIMMER BIOMET, INC.	N/A	679340

Patients

Seq	Age	Sex	Outcome	Treatment
1