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

Model Number	ACUMATCH GXL 15DEG LINER 32MM SZ H
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately sixteen years post initial tha, this male patient had a revision due to osteolysis.There is evidence of poly wear.Patient current status is stable.The devices are not available for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: p-series pf plasma collarless sz 4 12/14 (cat# 118-01-04 / serial# (b)(4)), acumatch cluster cup porous coated 56mm (cat# 120-01-56 / serial#(b)(4)), acumatch gxl 15deg liner 32mm sz h (cat# 132-32-28 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d10, g3, g6, h2, h3 and h6 have been updated accordingly.Section d10: concomitant medical product, 12/14 zirconia head 32mm +3.5mm neck (cat# 148-32-03 / serial# (b)(6)).(h3) the revision reported was likely the result of osteolysis which may have been due to patient conditions and/or the reported prosthesis wear.The wear was likely due to being implanted for approximately 15.5 years.However, this cannot be confirmed because the component was not returned for evaluation.The most probable root cause associated with the reported event of "osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.Furthermore, the most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Section d1: brand name section d4: model number, catalog number, serial number, expiration date, unique identifier (udi) # section g4: pma/510(k)number.Section h4: device manufacture date.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13578425
• Report Number: 1038671-2022-00212
• Device Sequence Number: 5539710
• 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: 2006
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 05/31/2010
• Device Model Number: ACUMATCH GXL 15DEG LINER 32MM SZ H
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2006
• 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: Male