MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	132-28-51
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, this patient had right hip replacement on (b)(6) 2011.They had revision surgery on (b)(6) 2022, approximately 11 years after their initial implantation.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
As a result of additional information received, the following fields have been updated.H6: investigation results - the revision reported may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear and osteolysis after being implanted for approximately 11 years.Additional contributing factors to the reported failures may have been the result of a combination of the risk factors specified in hhe 2020-09-11-02.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.
Event or Problem Description
As reported via legal documentation, this patient had right hip replacement on (b)(6) 2011 due osteoarthritis.They had revision surgery (b)(6) 2022, approximately 11 years after their initial implantation.Revision op report postoperative diagnosis: failed right total hip arthroplasty with impending wear through of polyethylene liner.The surgeon noted "the pseudocapsule and piriformis were damaged, likely from the previous approach.There is fluid tenting the capsule, which is causing this to be patulous", and "on entering joint, we see a large amount of wear related synovitis, clear synovial fluid and some metal staining, but preoperative fluid testing was negative for infection." the femoral component was provocatively tested and found to be well fixed.There was a massive osteolysis extending in all planes including the ischium, ilium, and medially.The patient transferred to recovery room in stable condition after reversal from anesthesia.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: NV GXL LNR, LIPPED, 28MM ID, GROUP 1 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 17033155
• Report Number: 1038671-2023-01185
• Device Sequence Number: 17885846
• Product Code: LZO
• UDI-Device Identifier: 10885862023155
• UDI-Public: 10885862023155
• 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: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Device Expiration Date: 05/12/2013
• Device Catalogue Number: 132-28-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2009
• 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: 76 YR
• Patient Sex: Female