MAUDE Adverse Event Report: ZIMMER, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: persona femur trabecular metal posterior stabilized (ps) narrow porous left catalog# 42500206201 lot# 62561635, persona articular surface catalog# 42511400711 lot# 62747270, patella catalog# 00587806532 lot# 62756941.

Event Description

It was reported that the patient has subsidence.However, no revision has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The physician assessment of postop radiographs stated the following: - no intraoperative adverse event reported.- no significant radiographic findings were reported from six-week post-surgery x-ray images.- radiolucency was identified on x-ray images six months post-surgery.- a 1mm circumferential gap was identified on x-ray images one year post-surgery.- subsidence and radiolucency were identified on x-ray images two years post-surgery.There were no x-ray or clinical changes, no pain or symptoms in the left knee.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The investigation determined that the likely root causes for the higher than anticipated complaint rate are that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices.Therefore, the problem with this device constitutes a "design issue" as the root cause.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 that the patient has tibial subsidence.However, no revision has been reported.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6251863
• MDR Text Key: 64882537
• Report Number: 0001822565-2017-00223
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007101
• Device Lot Number: 62758492
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR