FDA Adverse Event Injury Summary report: N

ZIMMER M/L TAPER FEMORAL STEM

MDR report key: 3902173 · Received May 7, 2014

Report

Report Number: 1822565-2014-00573
Event Type: Injury
Date Received: May 7, 2014
Date of Event: April 16, 2013
Report Date: April 9, 2014
Manufacturer: ZIMMER, INC.
Product Code: LZO
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OPERATIVE NOTES MENTION A BETADINE SCRUB AND IRRIGATION OF THE WOUND PRIOR TO CLOSURE. REVISION AND I AND D NOTES STATE THAT ASPIRATION PRODUCED GRAM-POSITIVE COCCI. THE INFECTION ONLY PRESENTED ITSELF 24 HOURS PRIOR TO REVISION, APPEARING AS RIGHT HIP PAIN AND AN ASSOCIATED FEVER. SINGLE-USE, STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE ZIMMER DEVICES CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. IT IS UNKNOWN IF ALL THAT PRECAUTIONS HAVE BEEN ABIDED TO, SUCH AS RECEIVING ANTIBIOTICS PRIOR TO DENTAL WORK. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS NOT SUSPECTED THA THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION OT THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT ALSO UNDERWENT AN IRRIGATION AND DEBRIDEMENT ON (B)(6) 2013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
275548	ZIMMER M/L TAPER FEMORAL STEM		LZO	ZIMMER, INC.		60270380

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Required Intervention