MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-22-11
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	10/18/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: - stem extension w/slot 120l x16 mm (cat# 204-36-12 / serial# (b)(6) - cc posterior fem augment sz 2, 5mm (cat# 208-07-02 / serial# (b)(6) - cc posterior fem augment sz 2, 5mm (cat# 208-07-02 / serial# (b)(6) - cc distal fem augment sz 2, 5mm (cat# 208-05-02 / serial# (b)(6) - cc distal fem augment sz 2, 5mm (cat# 208-05-02 / serial# (b)(6) - 3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(6) - cc stem ext adaptor 5 degree (cat# 208-09-05 / serial# (b)(6) - fluted stem extension 80l x 14 mm (cat# 204-34-08 / serial# (b)(6) - trapezoid tibial tray sz 1f/2t, 2f/2t (cat# 204-04-22 / serial# (b)(6) - cc femoral sz 2 (cat# 208-01-02 / serial# (b)(6).The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case (b)(6) case-2019-00005485 rk 2 stage rev1 case-2023-00007260 rk rev3 as reported by the legal brief a patient had a right knee revision on (b)(6) 2009, and continued to have pain and instability in connection with her optetrak knee replacement system it was determined that the device had again loosened and failed and was required to undergo another revision on (b)(6) 2012, approximately 3 years 8 months post revision.At this second revision, another insert was implanted in patient's knee.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Concomitant products: - stem extension w/slot 120l x16 mm (cat# 204-36-12 / serial# (b)(6) - cc posterior fem augment sz 2, 5mm (cat# 208-07-02 / serial# (b)(6) - cc posterior fem augment sz 2, 5mm (cat# 208-07-02 / serial# (b)(6) - cc distal fem augment sz 2, 5mm (cat# 208-05-02 / serial# (b)(6) - cc distal fem augment sz 2, 5mm (cat# 208-05-02 / serial# (b)(6) - 3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(6) - cc stem ext adaptor 5 degree (cat# 208-09-05 / serial# (b)(6 - fluted stem extension 80l x 14 mm (cat# 204-34-08 / serial# (b)(6) - trapezoid tibial tray sz 1f/2t, 2f/2t (cat# 204-04-22 / serial# (b)(6) - cc femoral sz 2 (cat# 208-01-02 / serial# (b)(6).510k: k954208.

• Brand Name: CC TIBIAL INSERT SZ 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20407617
• Report Number: 1038671-2024-03893
• Device Sequence Number: 6546427
• Product Code: JWH
• UDI-Device Identifier: 10885862054173
• UDI-Public: 10885862054173
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 208-22-11
• 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: 10/07/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2005
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - (11-2325) STRYKER 2000 90X13MM .050" 1.27MM (CAT
• Patient Sex: Female