FDA Adverse Event Malfunction Summary report: N

G7 BONEMASTER LTD ACET SHL 58G

MDR report key: 9106421 · Received September 23, 2019

Report

Report Number: 0001825034-2019-04221
Event Type: Malfunction
Date Received: September 23, 2019
Report Date: February 14, 2020
Manufacturer: ZIMMER BIOMET, INC.
Product Code: JDI
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED WITH PHOTOGRAPHS PROVIDED, WHICH SHOW THE OUTER STERILE PACKAGING IS CRACKED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED DEVIATIONS OR ANOMALIES DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TRANSIT DAMAGE. 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 IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. FOREIGN REPORT SOURCE: (B)(6). DEVICE IS NOT CLEARED UNDER A 510K, HOWEVER, IT IS SIMILAR TO DEVICES CLEARED UNDER K121874.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED THE STERILE PACKAGING WAS DAMAGED. SURGERY WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM WAS INDICATED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
901587	G7 BONEMASTER LTD ACET SHL 58G	PROSTHESIS, HIP	JDI	ZIMMER BIOMET, INC.	N/A	3246444

Patients

Seq	Age	Sex	Outcome	Treatment
1