FDA Adverse Event Injury Summary report: N

DELTA CER FEM HD 32/+3MM T1

MDR report key: 6960731 · Received October 19, 2017

Report

Report Number: 3002806535-2017-00963
Event Type: Injury
Date Received: October 19, 2017
Report Date: December 22, 2017
Manufacturer: BIOMET UK LTD.
Product Code: LZO
PMA / PMN Number: PK131684
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110003619, G7 ACETABULAR LINER CERAMIC 32 MM F, 3230050. 010000664, G7 PPS LTD ACET SHELL 54F, 3790818. 192013, ECHO POR FMRL NC 13 X 145 MM, 751010. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN THAT HAS LIMITED DAILY ACTIVITY. NO REVISION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
741214	DELTA CER FEM HD 32/+3MM T1	PROSTHESIS, HIP	LZO	BIOMET UK LTD.	N/A	2016021417

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Hospitalization\| O