FDA Adverse Event Injury Summary report: N

M2A-MAGNUM 42-50MM TPR INSRT-6

MDR report key: 10437249 · Received August 21, 2020

Report

Report Number: 0001825034-2020-03203
Event Type: Injury
Date Received: August 21, 2020
Date of Event: March 31, 2016
Report Date: August 17, 2020
Manufacturer: ZIMMER BIOMET, INC.
Product Code: KWA
PMA / PMN Number: K042037
Removal / Correction Number: NI
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCOMITANT MEDICAL DEVICES: 157450-M2A-MAGNUM MOD HD SZ 50MM-710640; US157856-M2A-MAGNUM PF CUP 56ODX50ID- 883830. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2016 - 01762 - 4, 0001825034 - 2020 - 03202. REPORTED EVENT WAS CONFIRMED VIA REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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. PRODUCT LOCATION UNKNOWN.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO ALTR, PAIN, AND LIMITED MOBILITY. DURING THE PROCEDURE SIGNIFICANT SCARRING WAS NOTED AROUND THE HIP CAPSULE. MAGNUM CUP, TAPER ADAPTER, AND HEAD WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
903656	M2A-MAGNUM 42-50MM TPR INSRT-6	PROSTHESIS, HIP	KWA	ZIMMER BIOMET, INC.	N/A	963150

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R