MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 32MM SZ H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	132-32-28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	05/12/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical product: 901773 118-41-03 - p-series pf plasma h/o collarless sz 3 12/14; 941453 120-01-56 - acumatch cluster cup porous coated 56mm; 932675 120-65-20 - bone screw 6.5mm dia x 20mm long; 702906 148-32-00 - 12/14 zirconia head 32mm +0mm neck.Z-1728-2022.
Event or Problem Description
As reported, the patient had an initial tha on (b)(6) 2007.The patient was revised on (b)(6) 2014; reason not reported.No other patient information/medical history reported.
Additional Manufacturer Narrative
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.However, this cannot be confirmed as no radiographs or photos were provided and the devices were not returned for evaluation.Correction: h6 clinical code and component code.

• Brand Name: ACUMATCH GXL 15DEG LINER 32MM 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: 17262939
• Report Number: 1038671-2023-01551
• Device Sequence Number: 8061426
• Product Code: JDI
• UDI-Device Identifier: 10885862023254
• UDI-Public: 10885862023254
• 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: 2007
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 09/19/2010
• Device Model Number: 132-32-28
• Device Catalogue Number: 132-32-28
• 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: 08/07/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2006
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown