MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR EXT SZ 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	190-31-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: ((b)(6)) 120-65-40 - bone screw 6.5mm dia x 40mm long, ((b)(6)) 170-36-00 - biolox delta femoral head 36mm od, +0mm, ((b)(6)) 186-01-60 - integrip cc, cluster 60mm, g4.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
12-sep-2024 additonal summary*** it is reported via legal documentation that patient is verified left hip on (b)(6) 2018 at (b)(6) medical center and patient had revision left hip on (b)(6) 2024.Pre/post op report: other mechanical complication of internal left hip prosthesis, initial encounter.Procedure: left total hip revision.Indications for surgery: (b)(6) is a 60 year-old male who is having surgery for other mechanical complication of left hip prothesis, initial encounter.Op notes: upon entering the prosthetic joint there was some clear fluid present.There were no signs of any deep purulence.The proximal portion of the femur was then exposed and an extraction device was connected to the stem.With 2 taps the entire stem came out and was grossly loose.I then debrided all of the fibrous tissue and the polyethylene wear debris that was in the proximal femur.The polyethylene liner was removed there was significant evidence of accelerated polyethylene wear at the superior portion of the poly.I then took out the 1 acetabular screw which had absolutely no purchase and evaluated the cup.When evaluating the cup, i got worried that i might have damaged the mechanism for the poly to lock into.Also felt like we had a little bit of retroversion of the acetabulum, at this point i used short and long blades from the zimmer cup out system and got around the acetabular shell and removed without problems, zimmer trials were sized, finals were impacted.Hip was placed through full rom.The hip was exquisitely stable in all planes of motion.A layered closure was performed.The patient was then flipped into the supine position and recovered from anesthesia.It is noted that there were no complications, and the patient tolerated the procedure well.Original summary it was reported via legal documentation that approximately 77 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Based on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, 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 most likely cause for the reported revision due to prosthesis wear and osteolysis may have been a combination of risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.H6: corrected health effect and investigation clinical codes.

• Brand Name: ALT HA S CLR EXT SZ 8
• Common Device Name: 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 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20251178
• Report Number: 1038671-2024-03605
• Device Sequence Number: 15476351
• Product Code: JDI
• UDI-Device Identifier: 10885862320971
• UDI-Public: 10885862320971
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 11/09/2022
• Device Catalogue Number: 190-31-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 11/13/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male