MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 28MM SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-28-25
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number: 1038671-2023-01338 d10 concomitants: (b)(6), 118-00-03 - p-ser 12/14 pf plasma collared sz 3, (b)(6), 148-28-93 - 12/14 zirconia head 28mm -3.5mm neck.The product associated with the reported event is within the scope of recall z-1728-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01338.The most likely underlying cause for the revision reported is prosthesis wear and acetabular loosening and 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 from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that a patient had a left total hip arthroplasty for arthritis on (b)(6) 2009 and then experienced a revision surgical procedure on(b)(6) 2016 approximately 7 years and 4 months after initial implant.Patient has experienced the following injuries including significant pain, and discomfort, gait impairment, poor balance, difficulty walking, component part loosening, prothesis wear, soft tissue damage, and bone loss.Patient was revised to competitor's devices/ postoperative diagnosis: left hip failed hip.Patient presented to the surgeon with pain and radiographic and clinical evidence of acetabular component failure.The femur was identified and examined and revealed a well-fixed femoral component.The acetabulum was inspected and did appear to have significant acetabular bone loss to the pubis, ischium and superior dome with gross distortion of the hemisphere.Findings: left hip with severe acetabular bone loss paprosky grade 2, grossly loose acetabular component.There were no intraoperative complications, the patient was taken to recovery room in stable condition.The patient passed away on (b)(6) 2022, though it is not indicated or suggested that it is as a result of these injuries.No images of the devices are provided.The device will not be returned.There is no other patient demographic or medical history available.No additional information is available.

• Brand Name: ACUMATCH GXL 15DEG LINER 28MM SZ E
• 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21257544
• Report Number: 1038671-2025-00511
• Device Sequence Number: 9117259
• Product Code: JDI
• UDI-Device Identifier: 10885862023070
• UDI-Public: 10885862023070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: 09/28/2007
• Device Catalogue Number: 132-28-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 09/30/2005
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female