MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A-SERIES CONNEXION GXL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	MCS GXL LINER 5/15 DEG 5458X32
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 76 yo male patient, initial right hip implanted on november 10, 2020, underwent a revision procedure on (b)(6) 2024, approximately 3 years 2 months post the initial procedure.The patient presented with pain.Radiographs showed wear.The surgeon decided to revise.No replacement liners were available, so the surgeon cemented a competitor¿s liner in the existing mcs cup.He put a replacement exactech 11/13 ball on the existing stem.The liner was cracked upon surgical dissection.All parts and pieces were removed.It appeared that the liner was not seated properly as the dome locking tab was sheared off.No surgical delays were reported.X-rays were provided.The patient was last known to be in stable condition following the event.No device returns for analysis anticipated.The devices were sent to pathology at the hospital per their protocol.Device images were provided.No further information.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of pain, prosthesis wear, and prosthesis fracture, as stated in the experience report.The prothesis wear and fracture may have been due to a combination of risk factors specified in the hhe, including but not limited to use error, implant positioning, and patient factors.The patient involved in this case meets the following risk criteria for early wear as specified in the hhe: significant edge loading of the femoral head on the acetabular liner.However, this cannot be confirmed because the devices were not available for evaluation and the extent of the prosthesis wear cannot be determined from the images provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, h6 problem code, component code, investigation findings, investigation conclusions.The revision reported may have been the result of pain, prosthesis wear, and prosthesis fracture, as stated in the experience report.The prothesis wear and fracture may have been due to a combination of risk factors including but not limited to use error, implant positioning, and patient factors.The patient involved in this case meets the following risk criteria for early wear: significant edge loading of the femoral head on the acetabular liner.However, this cannot be confirmed because the devices were not available for evaluation and the extent of the prosthesis wear cannot be determined from the images provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ACUMATCH A-SERIES CONNEXION GXL
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18654890
• Report Number: 1038671-2024-00168
• Device Sequence Number: 15519877
• Product Code: JDI
• UDI-Device Identifier: 10885862013606
• UDI-Public: 10885862013606
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2024
• Device Model Number: MCS GXL LINER 5/15 DEG 5458X32
• Device Catalogue Number: 104-32-45
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 11/18/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 05/28/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• 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-1728-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5746220 100-32-00 - COCR FEMORAL HEAD32MM+0MM NECK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male