ARCOMXL 32MM +3 MROM LNR SZ 22

Report

Report Number: 0001825034-2014-08005
Event Type: Injury
Date Received: October 7, 2014
Date of Event: October 17, 2014
Report Date: January 16, 2015
Manufacturer: BIOMET ORTHOPEDICS
Product Code: LZO
PMA / PMN Number: PK062997
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON A PREVIOUS MEDWATCH.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: PATIENT IDENTIFIER HAS BEEN CORRECTED IN THIS REPORT. THIS REPORT IS NUMBER 1 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08005-2 & 2015-00140 /-00141).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY.¿

Additional Manufacturer Narrative · 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. A CUSTOM UNIVERSAL RINGLOC CONSTRAINED LINER HAS BEEN REQUESTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT WAS REVISED DUE TO DISLOCATION AND A CUSTOM CONSTRAINED LINER WAS IMPLANTED (B)(6) 2014. IT WAS FURTHER REPORTED THAT THE PATIENT DISLOCATED A FEW WEEKS LATER AND UNDERWENT A SUBSEQUENT REVISION PROCEDURE ON (B)(6) 2014. ALL COMPONENTS WERE REMOVED AND A SECOND CUSTOM LINER AND RETAINING RING WERE REPLACED. BEFORE THE END OF THE PROCEDURE, THE NEW LINER AND CUP WERE REMOVED DUE TO ARTICULATION ISSUES AND REPLACED WITH COMPETITOR PRODUCTS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION AND A CUSTOM CONSTRAINED LINER WAS IMPLANTED ON (B)(6) 2014. IT WAS FURTHER REPORTED THAT THE PATIENT DISLOCATED A FEW WEEKS LATER AND UNDERWENT A SUBSEQUENT REVISION PROCEDURE ON (B)(6) 2014. ALL COMPONENTS WERE REMOVED AND THE SURGEON ATTEMPTED TO REUSE THE SAME CUSTOM LINER, NOT A NEW SECOND CUSTOM LINER, ALONG WITH A NEW LOCKING RING. HE WAS NOT HAPPY WITH THE WAY THE HIP WAS ARTICULATING AND BEFORE THE END OF THE PROCEDURE, THE LINER AND LOCKING RING WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. A CUSTOM UNIVERSAL RINGLOC CONSTRAINED LINER HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED REVEALED PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO DISLOCATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
629197	ARCOMXL 32MM +3 MROM LNR SZ 22	PROSTHESIS, HIP	LZO	BIOMET ORTHOPEDICS	N/A	571740

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention