MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVL HINGE LOCK RING; PROSTHESIS, KNEE

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the patient is being considered for a right knee arthroplasty revision approximately twenty years post-operatively to address component failure; however, the extent and nature of the failure is unknown.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

(b)(4).Concomitant devices - avl rotating hinge yoke 60mm x 16mm catalog #: rd119132 lot #: 350160, avl rotating hinge knee axle catalog #: rd119125 lot #: 406770, lombardi hinge knee femoral component 60mm right with porous coat catalog #:  cp111797 lot #: 606610, avl rotating hinged knee 60mm non-modular tibial base plate catalog #: cp111798 lot #: 569680, finn rotating hinged knee modular bond stem size 11.5mm x 152mm catalog #: cp111799 lot #: 569510, orthopedic salvage system locking pin catalog #: 150478 lot #: 223150, lombardi hinge femoral bushing catalog #: rd119021 lot #: 859300, avl rotating hinge knee tibial bushing set catalog #: rd119111 lot #: 411130, avl rotating hinge bearing 60mm x 16mm catalog #: rd119072 lot #: 395040, avl rotating hinged knee 5 degree hyperflexion bearing set 60mm x 12mm & 14mm & 16mm catalog #: cp111836 lot #: 569470.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-00481, 0001825034-2023-00483.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient is being considered for a right knee arthroplasty revision approximately twenty years post-operatively to address a dislodged locking ring.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

Review of radiographs confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.E1: full establishment name - (b)(6) medical center the additional information received does not affect or change the root cause of the previous investigation and it remains as: a definitive root cause cannot be determined.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 by the pmi group that a patient underwent a right knee arthroplasty approximately eleven (11) years ago to receive a custom implant due to a diagnosis of polio and drastic malalignment of the right knee joint.Subsequently, the patient is being considered for a pmi product on an unknown date due to fracturing of the lock ring component.Attempts have been made and no further information has been provided.

• Brand Name: AVL HINGE LOCK RING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16501331
• MDR Text Key: 310859712
• Report Number: 0001825034-2023-00482
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2002
• Device Model Number: N/A
• Device Catalogue Number: RD119120
• Device Lot Number: 336560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2002
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose