FDA Adverse Event Malfunction Summary report: N

MBT REV TIBIAL BROACH 29 MM

MDR report key: 10623941 · Received October 2, 2020

Report

Report Number: 1818910-2020-21558
Event Type: Malfunction
Date Received: October 2, 2020
Date of Event: September 21, 2020
Report Date: September 21, 2020
Manufacturer: DEPUY ORTHOPAEDICS INC US
Product Code: HTQ
UDI-DI: 10603295096078
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT OF WEAR. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

Additional Manufacturer Narrative · 1

(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PRODUCT D961673 IS WORN AND NEEDS TO BE REPLACED, THE BLACK END THAT GOES OVER THE IMPLANT TO TIGHTEN WAS SLIPPING WHEN THE SURGEON WAS PUTTING IMPLANTS TOGETHER. PRODUCT D217863109 AND D217863111 ARE NOT HOLDING STEM TRIALS WELL DUE TO THE WEAR AT THE CONNECTION SITE. NEEDS TO BE REPLACED. NO SURGICAL DELAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1085272	MBT REV TIBIAL BROACH 29 MM	KNEE INSTRUMENT : BROACHES	HTQ	DEPUY ORTHOPAEDICS INC US	2178-63-109		10603295096078

Patients

Seq	Age	Sex	Outcome	Treatment
1