MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a bfarm notification that 60 yo male patient underwent a revision approximately 4 years 9 months post an initial hip procedure, initial implant on (b)(6) 2017.An increased decentering of the head in the inlay impressed with clearly visible osteolysis in the bony interface area of the metal socket as a sign of a clear inlay wear stated.Puncture test administered on (b)(6) 2022, proved the absence of infection.Intraoperatively, it was verified solid bony integration, the change of the inlay to a highly cross-linked inlay (exactech xle), with change of the clip-on head and a curettage and sealing of cysts with allogeneic spongiosa.
Additional Manufacturer Narrative
Device return anticipated.(b)(6).Correction/removal number: z-2112 thru 2133-2021.Concomitant medical products: 180-01-56 - crown cup,cluster-hole gr.56, sn: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis, implanted with a lateralized liner and 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 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).The most likely cause for the bone fracture could not be determined as adequate information was not provided to conduct a review.However, bone fracture is captured in the product labeling.However, this cannot be confirmed from the reported information as radiographs were not provided and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from early prosthesis wear as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified in the hhe.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LNR, +5 LAT 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: kate jacobson ; 3523771140
• MDR Report Key: 15293630
• Report Number: 1038671-2022-00967
• Device Sequence Number: 15000650
• Product Code: JDI
• UDI-Device Identifier: 10885862024299
• UDI-Public: 10885862024299
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

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 Expiration Date: 11/12/2019
• Device Model Number: NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 136-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 04/21/2026
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/10/2022; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2014
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male