32MM MOD HEAD COCR STD NECK

Report

Report Number: 0001825034-2015-04161
Event Type: Injury
Date Received: October 5, 2015
Date of Event: September 18, 2015
Report Date: August 23, 2019
Manufacturer: CHANGZHOU BIOMET MEDICAL DEVICES CO.,LTD
Product Code: JDI
PMA / PMN Number: PK911684
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: DA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH AND TO CORRECT INFORMATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-04161 / 04162).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

Additional Manufacturer Narrative · 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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.¿ THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. (B)(4). THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-04161 / 04162).

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, PATIENT UNDERWENT A MANUAL MANIPULATION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION AND SUBLUXATION. IT WAS FURTHER REPORTED PATIENT UNDERWENT A MANUAL MANIPULATION PROCEDURE ON (B)(6) 2015 DUE TO SUBLUXATION.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, PATIENT UNDERWENT A MANUAL MANIPULATION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION AND SUBLUXATION. IT WAS FURTHER REPORTED PATIENT UNDERWENT A MANUAL MANIPULATION PROCEDURE ON (B)(6) 2015 DUE TO SUBLUXATION. ADDITIONAL INFORMATION RECEIVED REPORTED DURING THE (B)(6) 2015 REPOSITIONING, THERE WAS A MINOR CICATRICE PROBLEM; THE ISSUE WAS TREATED WITH MEDICATION AND RESOLVED ON (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT EXPERIENCED STRONG PAIN IN THE RIGHT THIGH ON (B)(6) 2016. THE ISSUE WAS TREATED WITH MEDICATION.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, PATIENT UNDERWENT A MANUAL MANIPULATION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION AND SUBLUXATION. IT WAS FURTHER REPORTED PATIENT UNDERWENT A MANUAL MANIPULATION PROCEDURE ON (B)(6) 2015 DUE TO SUBLUXATION. ADDITIONAL INFORMATION RECEIVED REPORTED DURING THE (B)(6) 2015 REPOSITIONING, THERE WAS A MINOR CICATRICE PROBLEM; THE ISSUE WAS TREATED WITH MEDICATION AND RESOLVED ON (B)(6) 2015.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, PATIENT UNDERWENT A NON-SURGICAL REPOSITIONING ON (B)(6) 2015 DUE TO DISLOCATION AND SUBLUXATION DURING A CHAIR ASCENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
658116	32MM MOD HEAD COCR STD NECK	PROSTHESIS, HIP	JDI	CHANGZHOU BIOMET MEDICAL DEVICES CO.,LTD	N/A	00J3516471

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention