FDA Adverse Event Injury Summary report: N

M/H HA POR LAT FMRL 11X160MM

MDR report key: 16833090 · Received April 28, 2023

Report

Report Number: 0001825034-2023-00919
Event Type: Injury
Date Received: April 28, 2023
Date of Event: December 21, 2022
Report Date: April 27, 2023
Manufacturer: ZIMMER BIOMET, INC.
Product Code: MEH
PMA / PMN Number: K021403
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

(B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-105865, RINGLOC LINER, 484060. 131158, MH SHELL, 320747. 163662, MOD HEAD, 792660. REPORT SOURCE AUSTRALIA. COMPONENT CODE: MECHANICAL (G04) STEM. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE STEM AND HEAD WERE EXPLANTED AND ARE COVERED IN BIO-DEBRIS. NO DAMAGE CAN BE SEEN ON THE STEM. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT PATIENT UNDERWENT 3 PREVIOUS HIP REVISION ACROSS A SPAN OF APPROXIMATELY 2 YEARS. SUBSEQUENTLY, APPROXIMATELY 13 YEARS LATER, THE PATIENT UNDERWENT A FOURTH HIP REVISION DUE TO BONE FRACTURE. 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
466173	M/H HA POR LAT FMRL 11X160MM	PROSTHESIS, HIP	MEH	ZIMMER BIOMET, INC.	N/A	520500

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Hospitalization\| R	SEE H10.