MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: partial femur cemented size 3 left medial, item# 42558000301, lot# 63729797.Partial articular surface left medial size e 8 mm thickness, item# 42518200508, lot# 63449771.Report source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient was revised approximately two years and ten months post implantation due to femoral loosening.Surgeon reported the patient had fallen six months post initial causing severe pain and swelling.Pain localized to tibial component of uni.Difficulty weight bearing.Investigations for infection negative.Plain radiographs suggested possible tibial component loosening posteriorly spect (isotope bone) ct (including radioisotope bone scan) demonstrated highly increased activity under posterior part of tibial component.No significant activity around femoral component or contralateral knee implant.Patient requested revision procedure.At surgery no sign of infection.Femoral component well fixed.Tibial component well fixed anteriorly but possible loosening posteriorly.Component exchange and re-cementation performed.There is no additional information at this time.

Manufacturer Narrative

No devices were received; therefore, the condition of the components is unknown.Photograph of the explanted tibial component shows some foreign material which is probably the bone growth.X-ray review by third party hcp states that there is radiolucency at the lateral and posterior margins of the tibial implant.These findings are consistent with osteolysis and possible implant loosening.There was osteolysis seen at the tibial implant.Review of the device history record identified no related deviations or anomalies during manufacturing.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 that a patient was revised approximately two years and ten months post implantation due to potential loosening of the unicompartmental tibial component, pain, and difficulty and.Surgeon reported the patient had fallen six months post initial causing severe pain and swelling.The tibial component was noted to be well fixed anteriorly but possibly loose posteriorly.Femoral component was well fixed.No additional information is available.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9384928
• MDR Text Key: 168463437
• Report Number: 0001825034-2019-04051
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812880
• UDI-Public: (01)00880304812880
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42538000501
• Device Lot Number: 63607706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 53