MAUDE Adverse Event Report: EXACTECH, INC. MCS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number MCS GXL LINER 5/15 DEG 5458X32

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event 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.

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.

• Brand Name: MCS
• 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 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18654890
• MDR Text Key: 334702673
• Report Number: 1038671-2024-00168
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862013606
• UDI-Public: 10885862013606
• Combination Product (y/n): N
• PMA/PMN Number: K051556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• 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-1728-2022
• Patient Sequence Number: 1
• Treatment: 5746220 100-32-00 - COCR FEMORAL HEAD32MM+0MM NECK.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male