MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants medical products: element-stem, collared w/ha, std offset, sz 11 (cat# 164-03-11), nv crown cup clstr hole 60mm group 4 (cat# 180-01-60), cocr femoral head 40mm, +0 offset 12/14 (cat# 142-40-00), 3.2mm drill bit 20mm 1pk (cat# 101-05-20), alteon 6.5mm screw, 15mm (cat# 180-65-15).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this (b)(6) patient presented to the emergency room with severe right hip pain.Ct and x-ray imaging show evidence of significant acetabular and femoral osteolysis and eccentricity of the femoral head in the acetabular liner.X-ray received.No additional information available.
Additional Manufacturer Narrative
Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis, implanted with a lateralized liner, and the combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the prosthesis wear/osteolysis reported is a combination of the risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.

• Brand Name: NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14372696
• Report Number: 1038671-2022-00548
• Device Sequence Number: 12208138
• Product Code: JDI
• UDI-Device Identifier: 10885862220318
• UDI-Public: 10885862220318
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS
• Device Catalogue Number: 136-40-54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-1732-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female