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	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 180-01-56 crown cup, cluster-hole gr.56 3690016.
Event or Problem Description
It was reported that this male patient's hip was revised approximately 8 years 6 months post op.In 2015, the patient had a hip prosthesis cup from exactech implanted on the left.In preparation for the implantation of a hip prosthesis on the right in 2022, a decentration of the inlay on the left was already noticed.Since the patient was symptom-free, the implantation was initially carried out on the right and check-ups on the left side were agreed every 6 months.As part of the manufacturer's recall and the planned check-ups, the patient presented for further check-ups.The x-ray and ct scan showed a clear decentration of the prosthesis head and minor osteolysis in the acetabulum as signs of inlay wear.With now increasing, mild complaints on the left side, the inlay was changed 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 socket was determined, the cysts in the socket were cured and filled using hydroxyapatite + calcium (ceramic bone void filler) and the prosthesis head was replaced.
Additional Manufacturer Narrative
H3: 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 prosthesis wear/osteolysis is a combination of the risk factors specified in an hhe.However, this cannot be confirmed because the devices were not available for evaluation, and no images or radiographs were provided.

• 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: 20242432
• Report Number: 1038671-2024-03577
• Device Sequence Number: 12604062
• 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: 2015
• 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
• Report Date (Section B): 12/02/2024

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: 11/27/2017
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2012
• Is the Device Labeled for Single Use? (Y/N): No
• 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