RINGLOC TRI-POLAR ACETABULAR SHELL

Report

Report Number: 0001825034-2018-01133
Event Type: Injury
Date Received: May 23, 2018
Date of Event: July 19, 2011
Report Date: May 23, 2018
Manufacturer: ZIMMER BIOMET, INC.
Product Code: KWY
PMA / PMN Number: PK911684
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-301351 ARCOS CON SZ A HI 80 MM 983940, 11-300615 ARCOS 15 X 200 MM PRX TPR DIST 956670, 11-165112 ALL-POLY TRI POLAR CUP 26 X 60 MM 627910, 163662 28 MM MOD HD STD NECK TP1 TAPER 063130 . REPORT SOURCE: STUDY. THE COMPLAINT WAS CONFIRMED BASED ON THE SURGICAL NOTES AND THE X-RAY THAT WERE PROVIDED. X-RAY REVIEW SHOWS SUPERIOR DISLOCATION. DEVICE HISTORY RECORDS WERE REVIEWED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES RELEVANT TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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: 0001825034-2017-11431. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD A DISLOCATION AND CLOSED REDUCTION TWO MONTHS PRE OP. THE PATIENT WAS FREE OF DISLOCATION FOR THREE MONTH WITH ABDUCTION BRACE. HOWEVER, FOUR DAYS LATER, AFTER REMOVE THE ABDUCTION BRACE, THE PATIENT HAD ANOTHER DISLOCATION AND CLOSED REDUCTION. NOW THE PATIENT WAS REVISED DUE TO RECURRING DISLOCATIONS AND INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
381016	RINGLOC TRI-POLAR ACETABULAR SHELL	PROSTHESIS, HIP	KWY	ZIMMER BIOMET, INC.	N/A	781610

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Hospitalization\| R