MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G4-60/62MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 36MM G4-60/62MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, surgeon performed a revision due to a failed gxl liner.X-rays received.No additional information received.
Additional Manufacturer Narrative
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 a2, a3, b5, b7, d1, d4, d6a, d10, g3, g4, g6, h2 and h4 have been updated accordingly.Section a2: age at the time of event.Section a3: gender.Section b5: describe event or problem.Section b7: other relevant history, including preexisting medical conditions.Section d1: brand name.Section d4: model number, catalog number, serial number, expiration date, unique identifier (udi) #.Section d6a: implant date.Section d10: concomitant medical products.Section g4: pma/510(k)number.Section h4: device manufacture date.Section b5: as reported, this 77-year-old male patient had a revision of left tha to replace the cup with a competitor¿s device due to a failed gxl liner.Surgeon used exactech femoral head and stem retained.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device is not available for evaluation due hospital keeps devices.Section d10: concomitants products - nv crown cup clstr hole 60mm group 4 (cat# 180-01-60).- biolox delta femoral head 36mm od, +0mm (cat# 170-36-00).- element-stem, collared w/ha, std offset, sz 12 (cat# 164-03-12).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 patient involved was reported for revision due to osteolysis/early prosthesis wear approximately 6.5 years after the index surgery.The prosthesis wear and osteolysis was able to be confirmed from the provided radiograph.However, the devices were not available for evaluation.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis, significant edge loading of the femoral head on the acetabular liner due to implant positioning and implanted with a lateralized liner.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors including, use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential could have all contributed to the increased trend in wear/osteolysis related complaints).Section h9 (z#s): z-2112 thru 2133-2021.

• Brand Name: NV GXL LNR, +5LAT, 36MM G4-60/62MM 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: 14343075
• Report Number: 1038671-2022-00541
• Device Sequence Number: 5221200
• Product Code: JDI
• UDI-Device Identifier: 10885862024343
• UDI-Public: 10885862024343
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2022

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: 07/10/2018
• Device Model Number: NV GXL LNR, +5LAT, 36MM G4-60/62MM CUPS
• Device Catalogue Number: 136-36-54
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 06/30/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/11/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2013
• 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-2112 THRU 2133-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - 3.2MM DRILL BIT 20MM 1PK; - ALTEON 6.5MM SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male