MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	138-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a total left hip arthroplasty on (b)(6) 2014, and then approximately 4 years, 9 months later experienced a revision surgery on (b)(6) 2019.Revision operative report of (b)(6) 2019: preoperative diagnoses: 1.Failed left total hip arthroplasty with severe cystic osteolysis and extreme polyethylene wear.2.Subacute posterior pelvic ring fracture through cystic osteolysis.3.Subacute anterior pelvic ring fracture through cystic osteolysis.Procedure performed: 1.Revision left total hip arthroplasty ¿acetabular component revised only via separate incision.2.Open reduction, internal fixation of left posterior pelvic ring fracture via separate incision.3.Open reduction, internal fixation of left anterior pelvic ring fracture via separate incision.Throughout the posterior aspect of the hip joint, particularly around the posterior column, there was reactive material consistent with cystic osteolysis and particulate disease.The posterior pelvic bone was very thin.The polyethylene in the acetabulum.It was severely eccentrically worn.There was an anterior lip and this lip was partially damaged and partially destroyed due to anterior impingement from the neck of the stem.In addition, there was severe eccentric wear.The thickness of the thinnest portion of the polyethylene was not more than a millimeter and, in some places, thinner than a millimeter.Removed the 54mm exactech socket quite easily with the explant (there were minimal areas of ingrowth).The cystic osteolysis membrane was removed.The acetabular cysts were curetted down to bleeding bone.Open reduction and internal fixation of the posterior pelvic ring fracture and the anterior pelvic ring fracture.The patient was taken to the recovery room in a stable manner.In the recovery room, he had active dorsiflexion of his left ankle and calf indicating the sciatic nerve was functional and functioning well.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.
Additional Manufacturer Narrative
H10.D10.Concomitants: (b)(6), 120-65-20 - bone screw 6.5mm dia x 20mm long; (b)(6), 120-65-25 - bone screw 6.5mm dia x 25mm long; (b)(6), 142-36-00 - cocr fem head 36mm +0 offset 12/14; (b)(6), 164-11-10 - novation element ro s/o sz 10; (b)(6), 180-01-54 - nv crown cup clstr hole 54mm group 2.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.
Additional Manufacturer Narrative
H10.H6.Investigation results- based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified in (b)(6).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.There is no other information available.

• Brand Name: NV GXL LNR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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
• MDR Report Key: 18095988
• Report Number: 1038671-2023-02722
• Device Sequence Number: 20500755
• Product Code: LZO
• UDI-Device Identifier: 10885862024886
• UDI-Public: 10885862024886
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2017
• Device Catalogue Number: 138-36-52
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male