MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Necrosis (1971); Pain (1994); Hypovolemia (2243)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00069, 0001822565-2020-00070, 0001822565-2020-00071, 0001822565-2020-00075, 0002648920-2020-00017, 0001822565-2020-00076, 0001822565-2020-00080, and 0001822565-2020-00081.Medical devices: articular surface with segmental hinge post size f 26 mm height catalog#: 00585006026 lot#: 61036887, cement shield hinge service kit size f catalog#: 00585007516 lot#: 62145974, tibial component precoat size 3 catalog#: 00588000300 lot#: 62128962, tibial block and screws precoat size 4 10 mm thickness catalog#: 00598800427 lot#: 60836308, stem extension sharp fluted 15mm dia x 75mm length catalog#: 00598801515 lot#: 61798489, stem extension sharp fluted 22mm dia x 75mm length catalog#: 00598801522 lot#: 60437392, palacos rg 1x40 single catalog: 00111314001 lot: 74624301, palacos rg 1x40 single catalog: 00111314001 lot: 74624301, trabecular metal tibial half block augment tapered right lateral / left medial with screws catalog#: 00544800429 lot#: 61787914, trabecular metal femoral augment block distal only catalog#: 00549003624 lot#: 61825154, trabecular metal femoral augment block distal only catalog#: 00549003624 lot#: 61825154.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a knee procedure.Subsequently, around five years later, the patient was revised due to pain and aseptic loosening.During the revision, heterotopic ossification and femoral necrosis were noted.

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.Updated: b4, g4, g7, h2, h3, h6, and h10.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during initial rhk implant surgery.In october 2017, the patient was present with aseptic loosening and pain.During this revision surgery, loose femur noted.Also, heterotopic ossification was noted and removed from the femur and tibial side.Also, necrosis pointed out in the femoral bone, and osteotomy performed.Additional work presented as the component had augments and stem.Also, the patella tendon was significantly complex, which was one of the reasons for extra time.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9559079
• MDR Text Key: 174132165
• Report Number: 0001822565-2020-00072
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 00588001601
• Device Lot Number: 60915244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 159