FDA Adverse Event Injury Summary report: N

ZIMMER INC

MDR report key: 4360723 · Received December 18, 2014

Report

Report Number
MW5039752
Event Type
Injury
Date Received
December 18, 2014
Date of Event
December 16, 2014
Report Date
December 18, 2014
Manufacturer
ZIMMER INC
Product Code
LZO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

SURGICAL COMPLICATION: RETAINED FEMORAL HEAD TRIALING COMPONENT. PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY WITH SPINAL ANESTHESIA ON (B)(6) 2014. DURING TO COURSE OF THE PROCEDURE, THE SURGEON WAS TRIALING FEMORAL COMPONENTS TO DETERMINE THE PROPER SIZE FOR THIS PATIENT. THE PATIENT WAS TEMPLATED TO AN EXTENDED OFFSET DUE TO AN EXTREME AMOUNT OF OFFSET IN HIS HIP; AN EXTENDED NECK OFFSET WAS USED. THE PATIENT WAS UNSTABLE ANTERIORLY AND THE HEAD SLIPPED THROUGH A RENT IN THE TISSUE WHERE THE OSTEOPHYTES AND REDUNDANT SOFT TISSUE HAD BEEN TAKEN OUT. THE FEMORAL HEAD STAYED ANTERIORLY IN THE PELVIS AND THE SURGEON WAS UNABLE TO FIND WHERE THE FEMORAL HEAD HAD MIGRATED TO (WITHIN THE PATIENT'S ANTERIOR PELVIS). AFTER CONSULTING WITH SURGEON PEERS, THE SURGEON AND FAMILY DETERMINED THAT THE INSTRUMENT SHOULD BE LEFT IN PLACE DUE TO THE RISKS ASSOCIATED WITH A LARGE INCISION THAT WOULD BE NEEDED TO RETRACT THE INSTRUMENT. THE REST OF THE PROCEDURE WAS PERFORMED AND THE PATIENT'S HIP WAS REPLACED APPROPRIATELY WITH +10.5 MM FEMORAL HEAD. CT SCAN OF THE PELVIS DETERMINED THAT THE FOREIGN BODY REMAINS BETWEEN THE RIGHT ILIAC WING AND ILIAC MUSCLE. FURTHER POSTOPERATIVE EVALUATION WILL BE NEEDED TO DETERMINE PLAN OF CARE FOR THIS PATIENT. TYPICALLY THE INSTRUMENT IS USED TEMPORARILY, FOR MEASUREMENT AND CAN BE STERILIZED FOR USE IN FUTURE SURGERIES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
831351 ZIMMER INC 36MM FEMORAL TRIAL HEAD +3.5 LZO ZIMMER INC

Patients

Seq Age Sex Outcome Treatment
1 51 YR Hospitalization| O 36MM FEMORAL TRIAL HEAD +3.5