MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 130-32-51

Device Problems Loss of Osseointegration (2408); Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2023

Event Type  Injury  

Event Description

It was reported that patient's gxl hip liner was revised due to wear and osteolysis.Cup & liner were replaced with competitors cup and liner.New exactech femoral heads implanted.Stem retained.Patient was last known to be in stable condition following the event.Product is not being returned due to being sent to pathology.

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): 101-05-20- 3.2mm drill bit 20mm 1pk.142-32-03- cocr fem head 32mm + 3.5 offset 12/14.164-13-10- novation element ro s/o col sz 10.180-65-20-alteon 6.5mm screw, 20mm.186-01-50- integrip cc cluster 50mm, g1.

Manufacturer Narrative

Section h10: (h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors specified in (b)(6).A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.The prosthesis wear and osteolysis could not be confirmed from the provided radiograph and images of the explanted devices, and the devices were not returned for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17165021
• MDR Text Key: 317540228
• Report Number: 1038671-2023-01405
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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 Operator: Health Professional
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1