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

Catalog Number	132-32-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	12/04/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had left hip replacement on (b)(6)2009.On or around (b)(6)2023, radiology studies demonstrated polyethylene wear, bone loss and osteolysis, in the setting of recalled implants, leading to the recommendation for explantation, which is tentatively planned for the fall of 2023.The patient has additionally suffered bilateral hip osteolysis and bone loss and will, upon information and belief, require bilateral hip prostheses explantation in the near future.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: e1, e2, e3, g2, 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 prosthesis wear, and osteolysis.The prothesis wear and osteolysis may have been due to a combination of risk factors specified in the hhe and being implanted for more than 10 years.Including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed from the information provided and it is unclear if the patient has been revised at this time.

• Brand Name: NV GXL LNR, LIPPED, 32MM ID, GROUP 3 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523782617
• MDR Report Key: 17401515
• Report Number: 1038671-2023-01789
• Device Sequence Number: 12677046
• Product Code: LZO
• 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: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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: 09/28/2012
• Device Catalogue Number: 132-32-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 04/23/2024; 05/14/2026
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 04/29/2024; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown