MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH A SERIES; ACUMATCH GXL 0 DEGREE LINER 32MM SZ G

Model Number	130-32-27
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: (cn: 140-32-03, sn: (b)(4) biolox femoral head 12/14, 32mm.
Event or Problem Description
As reported, approximately 10 years postoperatively completed a revision of the right hip.An x-ray was taken of right hip revealed there was some eccentric wear on the poly.The patient experienced some "clunking" when walking.Devices not returned due to hospital policy.Patient was last known to be in stable condition following the event.Patient is average size (b)(6) y/o female.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of prosthesis wear which may have been due to edge loading/impingement, orientation of the acetabular cup, and/or patient related factors.However, this cannot be confirmed because the component was not returned for evaluation and x-rays were not provided.(d11) concomitant devices: (cn: 140-32-03, sn: (b)(4) ) biolox femoral head 12/14, 32mm.Section(s): no information has been provided: a2, a4, a5, and b6.The following section(s) have additional info; a2, a3, b7, g4, g7, h1, h2, h3, and h7.

• Brand Name: ACUMATCH A SERIES
• Common Device Name: ACUMATCH GXL 0 DEGREE LINER 32MM SZ G
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9746307
• Report Number: 1038671-2020-00215
• Device Sequence Number: 1974773
• Product Code: JDI
• UDI-Device Identifier: 10885862022097
• UDI-Public: 10885862022097
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 10/03/2011
• Device Model Number: 130-32-27
• Device Catalogue Number: 130-32-27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR