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

Catalog Number	132-28-24
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2011, and then experienced revision surgical procedure on (b)(6) 2018 approximately 7 years and 6 months after initial implant.No images were provided.There is no other information available.
Additional Manufacturer Narrative
D10.Concomitant: 120-01-44 - acumatch cluster cup porous coated 44mm; (b)(6).This device is used in treatment and not in diagnosis.Pending investigation.
Additional Manufacturer Narrative
1038671-2024-00639 b1: corrected.B2: corrected.C6: corrected the following: health effect - clinical code, type of investigation, investigation findings, investigation conclusions.Manufacturer narrative: the most likely cause for the reported revision due to prosthesis wear and osteolysis is a combination of the 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).Additionally, a contributing factor may have been using another manufacturer¿s femoral components with exactech acetabular components.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: ACUMATCH GXL 15DEG LINER 28MM SZ D
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: michael crader
• MDR Report Key: 18957686
• Report Number: 1038671-2024-00639
• Device Sequence Number: 4449604
• Product Code: LZO
• UDI-Device Identifier: 10885862023063
• UDI-Public: 10885862023063
• 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: 2011
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2013
• Device Catalogue Number: 132-28-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2009
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female