MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 36MM SZ H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	132-36-28
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tha on (b)(6)2007.The patient had a previous revision on (b)(6)2014.The patient was revised again on (b)(6)2023 due to pain, wear and severe osteolysis on ct scan, per the surgeon.No issues with surgery.Revised to a competitors cage and dual mobility.A new 22mm metal head was also used.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 170-36-50 - biolox delta option femoral head 36mm od.(b)(6), 170-50-00 - biolox delta adapter 16/18-12/14; +0mm.(b)(6), 652-00-05 - optecure with ccc - 5cc.(b)(6), 652-00-05 - optecure with ccc - 5cc.(b)(6), 652-00-05 - optecure with ccc - 5cc.H7: z-1728-2022.
Additional Manufacturer Narrative
H3: the revision reported 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.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
Correction: h3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: significant edge loading of the femoral head on the acetabular liner.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors specified in the hhe.The prosthesis wear was able to be confirmed from the provided radiograph and image of explanted devices.H6: component code, investigation findings, investigation conclusions.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, type of investigation, component code.

• Brand Name: ACUMATCH GXL 15DEG LINER 36MM SZ H
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17262963
• Report Number: 1038671-2023-01552
• Device Sequence Number: 18120585
• Product Code: JDI
• UDI-Device Identifier: 10885862023391
• UDI-Public: 10885862023391
• 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: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2024

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: 06/14/2017
• Device Model Number: 132-36-28
• Device Catalogue Number: 132-36-28
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 03/05/2024; 08/15/2024; 08/15/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 03/21/2024; 08/15/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2012
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown