MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)).Cemented finned tib.Tra sz 2f/2t (cat# 200-04-22 / serial# (b)(4)).Optetrak asy,cr cemented femoral, sz 2 (cat# 230-03-02 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately eleven years post initial tka, this female patient has a scheduled revision to be done for an unknown reason.No additional information is available.
Additional Manufacturer Narrative
After further review of additional information received the following sections a2, a4, b5, d6b, g3, g6, h2 and h6 have been updated accordingly.Section b5: additional information received indicates that this is a 65 y/o and 160 lbs.Female patient with no significant medical history.Patient revision was on monday (b)(6) 2022.Patient went to see surgeon as she was referred by initial surgeon.Patient was experiencing pain with ambulation, swelling.The indication for patient's revision was articular wear seen on radiographs, osteolysis.Intraop patient had severe poly wear posteriorly (mostly lateral but also medial).There was catastrophic failure of the metal tibial baseplate with metal wear posteriorly.Severe metalosis throughout the knee and severe osteolysis of the femur and tibia.Revision required metaphyseal sleeves due to bone loss.The device is not available for evaluation.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) the revision reported was likely due to progressive prosthesis wear over 11 years of implantation secondary to mechanical overload on the posterior and lateral edge of the tibial insert leading to full thickness polyethylene wear, metallic wear of the tibial tray and subsequent osteolysis.Contributions from overall slope of the insert and tibial tray, rotational malalignment and/or potential ligamentous/soft tissue imbalances may have allowed for excessive posterior contact leading to wear of the polyethylene insert.However, the contributions of individual factors or a combination of the aforemention factors cannot be confirmed as the devices were not available for evaluation and additional information was not provided.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.

• Brand Name: CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
• Common Device Name: 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: 13944690
• Report Number: 1038671-2022-00310
• Device Sequence Number: 14605398
• Product Code: JWH
• UDI-Device Identifier: 10885862041227
• UDI-Public: 10885862041227
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2013
• Device Model Number: CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
• Device Catalogue Number: 200-72-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/31/2022; 09/23/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 08/23/2022; 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 73 KG