FDA Adverse Event Injury Summary report: N

M2A-MAGNUM PF CUP 50ODX44ID

MDR report key: 9108835 · Received September 24, 2019

Report

Report Number: 0001825034-2019-04239
Event Type: Injury
Date Received: September 24, 2019
Date of Event: February 27, 2018
Report Date: September 23, 2019
Manufacturer: ZIMMER BIOMET, INC.
Product Code: LPH
PMA / PMN Number: K101336
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 157444, M2A-MAGNUM MOD HD SZ 44MM, LOT: 189150, PART: 139256, M2A-MAGNUM 42-50 TPR INSRT STD, LOT: 872110, PART: X12-171310, INTEGRAL/X POR RED PROX 10MM, LOT: 087460. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING PATIENT EXPERIENCING PAIN AND DARK MATERIAL FOUND WITHIN THE SYNOVIUM. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -03068, 0001825034 -2019 -03067.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY, ALMOST TEN YEARS LATER, THE PATIENT WAS REVISED DUE TO A PAINFUL LEFT HIP. DURING THE REVISION, DARK MATERIAL WAS NOTED WITHIN THE SYNOVIUM. HEAD AND NECK REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
907101	M2A-MAGNUM PF CUP 50ODX44ID	PROSTHESIS, HIP	LPH	ZIMMER BIOMET, INC.	N/A	330620

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R