MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ACETABULAR COMPONENTS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had a revision for an unknown reason.Patient was revised to cc inlay vitamin e, neutral, ø 36, gr.3 (cat# 140-36-63 / serial# (b)(6).No further information at this time.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
No devices were returned for evaluation and no radiographs, images, operative notes, or patient medical history information were provided for review.It is possible this event is associated with polyethylene wear for which a number of variables including use error, implant positioning, implant selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) can be contributors.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh (subject of the associated fsca 18832/21) could also contribute to wear.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified in an hhe.However, this cannot be confirmed from the reported information.
Additional Manufacturer Narrative
D10: concomitant products: crown cup inlay,lat.+5 gr.3,32mm (cat# 136-32-53 / serial# (b)(6)).Crown cup,cluster-hole gr.56 (cat# 180-01-56 / serial# (b)(6)).
Event or Problem Description
As reported by the germany competent authorities and as part of the manufacturer's recall campaign, the patient went to have both hip prostheses checked (left implanted in 2019, right in 2021).The x-ray and ct check showed clear decentration both prosthetic heads with unusually large osteolysis in both acetabula as a sign of premature inlay wear.First, the right side was revised on (b)(6) 2023.The suspected diagnosis was confirmed and the inlay was replaced with a specially approved vitd-hardened one inlay (novation xle, neutral liner, group 3, 36 mm i.D., ref 140-36-53, sn (b)(6)).As part of the exchange operation, in addition to the inlay exchange, the solid cup integrity was determined as well as curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.The explants are currently with hospital and will be returned to the patient at their own request handed out.No further information provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6-clinical code, components code, the following sections were corrected: clinical code 1924, component code 4756, type of inv 4112, 4109 no longer applies.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, d6b, h4, h6.Mdr section codes updated/corrected: b, e.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the 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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 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: geoff gannon
• MDR Report Key: 18480248
• Report Number: 1038671-2024-00055
• Device Sequence Number: 20554375
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/12/2025

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: 08/20/2022
• Device Model Number: ACETABULAR COMPONENTS
• Device Catalogue Number: 130-32-53
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/03/2024; 06/07/2024; 05/19/2025; 11/12/2025
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 06/27/2024; 07/24/2024; 05/22/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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
• Patient Sex: Male