MAUDE Adverse Event Report: EXACTECH, INC. CUP, CLUSTER-HOLE, 44MM GROUP 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	180-01-44
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6), 160-00-10 - pf stem tapered plasma sz10.(b)(6), 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.
Event or Problem Description
As reported, approximately 5.5 years post the initial left total hip arthroplasty, the patient complained of hip pain.The surgeon diagnosed wear or damage of the liner and revision surgery to replace the liner and femoral head was performed.Breakage on the rim of the liner was observed.The surgeon decided there was no loosening of the acetabular cup and femoral stem to bone.The liner and femoral head were replaced to an xle liner and delta head with adaptor.The polyethylene particles on the surgical field were resected by the surgeon appropriately.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: CUP, CLUSTER-HOLE, 44MM GROUP 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22122140
• Report Number: 1038671-2025-02205
• Device Sequence Number: 20622257
• Product Code: MEH
• UDI-Device Identifier: 10885862036971
• UDI-Public: 10885862036971
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2022
• Device Catalogue Number: 180-01-44
• 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: 05/13/2025
• Initial Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 07/11/2017
• 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
• Patient Sex: Female