MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS RS NON MOD PLATE LONG 67; KNEE PROSTHESIS

Model Number N/A

Device Problems Disassembly (1168); Migration or Expulsion of Device (1395)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 178717 cps 10cm seg fm oss tpr lt 570740, 178710 cps taper locking cap / oss sc 608540, 161039 oss rs non mod plate long 67 755040, 178554 cps short anchor plug 12mm 805180, 178363 cps xs sht spdl w pins 600lbf 389070, 178512 cps nut co-cr-mo alloy 524860, 150476 oss poly tibial bushing 036780, 178526 cps transverse pin 6pk 28mm 524850, 178538 cps transverse pin 6pk 28mm 524850, 178538 cps centering sleeve 16mm 324780, 150478 oss poly lock pin 037040, 150477 oss poly femoral bushings 2pk 232870, 150493 oss reinforced yoke 321890, 150480 oss axle 807390.(b)(6).Reported event was confirmed by review of x-rays provided.X-rays were sent to hcp for additional review, their review noted a dislodged screw in the posterior joint recess.Also noted on the lateral view is periprosthetic lucency between the posterior tibial plate and the bone.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Event Description

It was reported the patient underwent an orthopedic salvage procedure.Subsequently, the patient underwent a revision procedure approximately four years post-implantation due to loosening of the last fixation screw through the femoral block of the distal femoral resection prosthesis.The surgeon was concerned that the loose screw was causing blockage of the knee joint and could possibly damage the metal prosthetic surface and articular surface.

• Brand Name: OSS RS NON MOD PLATE LONG 67
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7313102
• MDR Text Key: 101492809
• Report Number: 0001825034-2018-01656
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PK051479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 161039
• Device Lot Number: 755040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 50