MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number OPTETRAK PS TIBIAL INSERT

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2021

Event Type  Injury  

Event Description

As reported, approximately six months post right tka implantation, a (b)(6) female patient had anterior knee pain and a poly and patella exchange was made.There were no parts or pieces fell into the patient wound area.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device will be return.

Manufacturer Narrative

Concomitant medical products: logic stem ext 12mm x 80mm (cat# 02-012-60-1280 / serial# (b)(4)); three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)); cc distal fem augment sz 2, 10mm (cat# 208-06-02 / (b)(4)); cc distal fem augment sz 2, 10mm (cat# 208-06-02 / serial# (b)(4)); logic offset stem ext coupler 6mm (cat# 02-012-61-6000 / serial# (b)(4)); logic post.Aug.Block size 2, 10mm (cat# 02-010-06-0522 / serial# (b)(4)); logic cc femoral size 2, left (cat# 02-010-06-0220 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

Section d10: concomitant medical products: optetrak 3-peg patella.

Manufacturer Narrative

The revision reported may have been the result of rotational mismatch between the femoral and tibial components and patient-related conditions, which led to polyethylene wear on both the tibial insert and patella and caused the reported anterior knee pain.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

Manufacturer Narrative

Section h11: the following sections have corrected information: (d1) brand name: ps tibial inserts sz 2, 9mm, (d4) catalog number: 204-22-09, unique identifier (udi) #: (b)(4).(d10) concomitant devices: 200-02-29, (b)(6) - patella.02-012-60-1280, (b)(6) - logic stem ext 12mm x 80mm.208-06-02, (b)(6) - cc distal fem augment sz 2, 10mm.208-06-02, (b)(6) - cc distal fem augment sz 2, 10mm.02-012-44-2013, (b)(6) - logic tibia implant psc insert, sz 2, 13mm.02-012-61-6000, (b)(6) - logic offset stem ext coupler 6mm.02-010-06-0522, (b)(6) - logic post.Aug.Block size 2, 10mm.02-010-06-0220, (b)(6) - logic cc femoral size 2, left.(g4) pma/510(k)number: k932690.(h3) the revision reported was likely due to axial rotational mismatch between the femoral and tibial components, third-body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear on the tibial insert and the patella causing the reported anterior knee pain.

• Brand Name: PS TIBIAL INSERTS SZ 2, 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13122488
• MDR Text Key: 285677769
• Report Number: 1038671-2021-00739
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862048226
• UDI-Public: 10885862048226
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K932690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2024

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 Expiration Date: 08/26/2022
• Device Model Number: OPTETRAK PS TIBIAL INSERT
• Device Catalogue Number: 204-22-09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/12/2022; 04/21/2022; Not provided
• Supplement Dates FDA Received: 01/31/2022; 05/25/2022; 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 102 KG