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

Catalog Number	130-32-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6) 180-01-58 - crown cup,cluster-hole gr.58.
Event or Problem Description
It was reported that this male patient's hip was revised approximately 4 years 6 months post op.The patient had a hip prosthesis cup from exactech implanted.During the course of the procedure, the stem became loose and sintered, which is why a stem replacement operation was carried out, during which the cup inlay was also replaced (old: novation crown cup, connexion gxl, neutral liner, group 3, 32mm).As part of the manufacturer's recall, the patient came in for a check-up.The x-ray and ct scan showed a slight decentration of the prosthesis head, small osteolyses in the acetabulum and a larger osteolysis in the stem area as signs of inlay wear.This was verified during an inlay change to a vit e-hardened, specially approved inlay (novation xle, neutral liner, group 3, 36 mm).As part of the replacement operation, in addition to the inlay exchange, the firm integrity of the cup and shaft was determined, the cysts in the cup bed were curettaged and filled using hydroxyapatite + calcium (ceramic bone void filler) and the prosthesis head was replaced.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6.H3: 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 manufacturing data was performed and no discrepancies were found.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, the revision reported may have been due to a combination of risk factors specified in an hhe including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed because the components were not returned to exactech for evaluation and no images or pre-revision radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were updated: e1 the following sections were corrected: b2 d1 d4: catalog number and udi based on the available information, the revision reported may have been due to 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) including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed because the components were not returned to exactech for evaluation and no images or pre-revision radiographs were provided.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, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20233573
• Report Number: 1038671-2024-03549
• Device Sequence Number: 15487454
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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: 10/07/2023
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 12/13/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 12/31/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male