MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5 LAT 32MM ID, GROUP 4 CUPS; SEE H10

Catalog Number	136-32-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Osteolysis (2377)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10.Concomitants: (b)(6), 180-01-60 - crown cup,cluster-hole gr.60.(b)(6), 11-000-440 sl-plus integration plus mia stern lateral with ti/ha (smith & nephew).(b)(6), 71343208 oxinium 32mm o.D.+8 12/14 taper femoral head (smith & nephew).These devices are used for treatment not diagnosis.Pending investigation.
Event or Problem Description
It was reported via legal documentation from ous that the patient had a left total hip replacement for coxarthrosis on (b)(6) 2018.The patient had inpatient rehabilitation from (b)(6) 2018 to (b)(6) 2018.The patient was informed on 20 apr 2023 about a recall of his hip device.He had a check-up in (b)(6) 2023, it was determined there that the hip implant had already caused the hip joint to decenter in the socket.Based on these findings, the treating doctors recommended that the patient replace the implant.The revision operation has been scheduled for (b)(6) 2024.Subsequent examinations and the documents from the check-up, confirmed the suspicion that the implant was showing considerable wear and tear and needed to be replaced as quickly as possible, which is why the treating doctors determined that it needed to be revised immediately.The patient claims pain.It is noted that this total implant contains device from two separate companies.There is no other patient demographic or medical history provided.There are no images of the patient/device provided.
Additional Manufacturer Narrative
H10.Additional/updated information- b3, b5, d6b h6.Investigation results- based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified for use of a lateralized liner.The most likely cause for the revision reported due to early prosthesis wear is a combination of the risk factors.Additionally, the exactech acetabular components were used in combination with a competitor¿s femoral components which is considered off-label use.However, prosthesis wear cannot be confirmed as radiographs were not provided and the devices remained implanted at the time of evaluation.There is no other information available.
Event or Problem Description
The x-ray control showed a clear decentering of the prosthetic head and unusually large osteolysis in the acetabulum as a sign of inlay wear.Revision on (b)(6) 2024.
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, impact code, component code, investigation type, investigation findings.The following sections were corrected: h6: impact code (appropriate health impact term not available), investigation type (historical data analysis), investigation findings (wear problem) no longer applies.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NV GXL LNR, +5 LAT 32MM ID, GROUP 4 CUPS
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17816558
• Report Number: 1038671-2023-02372
• Device Sequence Number: 20364610
• Product Code: LZO
• UDI-Device Identifier: 10885862024305
• UDI-Public: 10885862024305
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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: 10/15/2019
• Device Catalogue Number: 136-32-54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 06/10/2025
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 01/24/2024; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male