FDA Adverse Event Injury Summary report: N

DELTA CER FEM HD 32/0MM T1 M T1

MDR report key: 7285301 · Received February 21, 2018

Report

Report Number: 3002806535-2018-00379
Event Type: Injury
Date Received: February 21, 2018
Date of Event: January 9, 2017
Report Date: February 20, 2018
Manufacturer: BIOMET UK LTD.
Product Code: LZO
PMA / PMN Number: PN/A
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: DA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4) CONCOMITANT MEDICAL PRODUCT - RLOC-X ARCOMXL H/W 50/32 MM 23 23 ITEM # XL-053250, LOT # 30388546 (REMAINS IMPLANTED). CONCOMITANT MEDICAL PRODUCT - EXC ABT RNGLC-X SHELL PC 050 MM DIA50MM, ITEM # 131350, LOT # 3417600 (REMAINS IMPLANTED). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-00380 AND 3002806535-2018-00381.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY DUE TO PAIN IN THE RIGHT HIP WHEN SITTING IN THE CHAIR, THE PATIENT WAS SEEN BY THE SURGEON. PATIENT WAS DIAGNOSED WITH TROCHANTER BURSITIS WHICH WAS TREATED WITH A STEROID BLOCKADE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
129005	DELTA CER FEM HD 32/0MM T1 M T1		LZO	BIOMET UK LTD.	N/A	3386519

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention