MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: (b)(6) - 164-11-12 - novation element ro s/o sz 12 (b)(6) - 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6) - 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) - 180-65-40 - alteon 6.5mm screw, 40mm.(b)(6) - 186-01-52 - integrip cc, cluster 52mm, g2.The product associated with the reported event is within the scope of recall z-1732-2022; 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
It was reported that approximately 66 months after a right total knee replacement procedure, the patient has experienced prosthesis wear, pain and difficulty walking.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, type of investigation.Based on the available information, the patient involved in incident meets the following risk criteria for early prosthesis wear and/or osteolysis: combination of largest available femoral head and/or thinnest available liner was used.The most likely underlying cause for the revision reported is a combination of risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed from the reported information and the devices were not available for evaluation.

• Brand Name: NV GXL LINER LIPPED 36MM ID GROUP 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 20146660
• Report Number: 1038671-2024-03316
• Device Sequence Number: 14515130
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: 132-36-52
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female