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

Model Number SPECIFIC DEVICE NOT REPORTED

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Subluxation (4525); Insufficient Information (4580)

Event Date 02/23/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event Description

As reported via legal documentation the patient had a left hip replacement on (b)(6) 2012.Approximately 10 years and 8 months after the initial procedure the patient had a left hip revision on (b)(6) 2023.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.

Manufacturer Narrative

H6: investigation results: the revision reported was likely the result of prosthesis wear and dislocation.The extent and root cause of the prosthesis wear and dislocation could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.

Event Description

Revision operative report of (b)(6) 2023: postoperative diagnosis: left total hip liner wear.Name of operation: revision left total hip femoral head and liner swap.Indications: the patient is a 75-year-old male status post left total hip arthroplasty experiencing premature liner wear.Previously, patient had had subluxation issues, also indicated for a femoral head replacement.Procedure: the pseudo capsule fibrous tissue was resected to expose the femoral head.Soft tissue was subsequently sent for culture.Once the femoral head was subluxed, retractors were placed around the acetabular cup.A 2.5 mm drill bit was drilled into the acetabular liner, followed by insertion of a 3.5 mm cortical screw, which dislocated and removed the acetabular cup.A new acetabular liner was then inserted and impacted into place and noted to be secure.Next, we then removed the femoral head, which was a -3.5 x 36 mm head.A biolox option head was then inserted, which was +3.5 x 36 mm reduced into place and noted to be stable through the full arc of motion without any dislocation of the hip.A sterile dressing was applied.Prognosis: patient is weightbearing as tolerated; follow up with x-rays in 2 weeks.There is no other information available.

Manufacturer Narrative

H10.Additional/updated information - a2, a3, b1, b5, b6, b7, d1, d2a, d2b,d4 all, d10, g2, g4 510k, h4, h6 health effect - clinical code & medical device problem code, h7, h8, & h9 d10.Concomitants: 2069696 142-36-93 - cocr fem head 36mm -3.5 offset 12/14 2356396 164-01-12 - element-stem, collarless w/ha, std offset, sz 12 2351812 180-01-56 - nv crown cup clstr hole 56mm group 3.There is no other information available.Pending investigation.

• Brand Name: NV GXL LINR, NTRL
• Type of Device: 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17488215
• MDR Text Key: 320678899
• Report Number: 1038671-2023-01914
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2017
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 130-36-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1729-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male